Vascular Solutions, Inc.: FDA filings under this applicant name
FDA lists 115 510(k) clearances under the applicant name “Vascular Solutions, Inc.” (first 2002, latest 2024), plus 1 PMA decision, across 18 product codes in 4 review panels. Median 510(k) review time under this name: 79 days. Since 2017 the median was 90 days, against 105 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Teleflex, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 192 |
| 2013 | 0 | — |
| 2014 | 5 | 118 |
| 2015 | 2 | 155 |
| 2016 | 3 | 90 |
| 2017 | 10 | 103 |
| 2018 | 6 | 30 |
| 2019 | 2 | 116 |
| 2020 | 3 | 128 |
| 2021 | 1 | 58 |
| 2022 | 4 | 186 |
| 2023 | 1 | 59 |
| 2024 | 1 | 192 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Vascular Solutions, Inc. took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 105 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQY | Catheter, Percutaneous | 27 | 27 |
| QSX | Hemostatic Wound Dressing With Thrombin Or Other Biologics | 18 | 18 |
| GEX | Powered Laser Surgical Instrument | 13 | 13 |
| QEZ | Aspiration Thrombectomy Catheter | 13 | 13 |
| DQO | Catheter, Intravascular, Diagnostic | 12 | 12 |
| DQX | Wire, Guide, Catheter | 11 | 11 |
| KRD | Device, Vascular, For Promoting Embolization | 5 | 5 |
| DXC | Clamp, Vascular | 3 | 3 |
| DYB | Introducer, Catheter | 3 | 3 |
| FMF | Syringe, Piston | 2 | 2 |
Plus 8 more product codes.
Review panels
Most recent Vascular Solutions, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233729 | Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon catheter, 2.50 x 20mm (5882); Ringer perfusion balloon catheter, 2.50 x 30mm (5883); Ringer perfusion balloon catheter, 3.00 x 20mm (5884); Ringer perfusion balloon catheter, 3.00 x 30mm (5885); Ringer perfusion balloon catheter, 3.50 x 20mm (5886); Ringer perfusion balloon catheter, 3.50 x 30mm (5887); Ringer perfusion balloon catheter, 4.00 x 20mm (5888); Ringer perfusion balloon catheter, 4.00 x 30mm (58 | LOX | 2024-05-31 | 192 |
| K230637 | Wattson temporary pacing guidewire (2250) | DQX | 2023-05-05 | 59 |
| K220647 | GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272); GuideLiner Coast, 8F (5273) | DQY | 2022-08-18 | 164 |
| K221470 | Langston dual lumen catheter | DQO | 2022-06-17 | 28 |
| K212211 | Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter | DQY | 2022-02-09 | 209 |
| K212167 | R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire | DQX | 2022-02-09 | 212 |
| K210647 | SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter | DQY | 2021-04-30 | 58 |
| K193119 | Twin-Pass Dual Access Catheter | DQY | 2020-06-29 | 230 |
| K200720 | D-Stat Radial Topical Hemostat | QSX | 2020-06-26 | 99 |
| K192454 | Wattson Temporary Pacing Guidewire | DQX | 2020-01-15 | 128 |
105 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P990037 | PMA | VASCULAR SOLUTIONS DUETT SEALING DEVICE | 2000-06-22 |
Recalls
29 product recalls in 22 recall events; 0 initiated in the last five years. Most recent: 2020-08-31.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Vascular Solutions, Inc. is the lead sponsor of 6 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04849169: Investigation of the Ringer Perfusion Balloon Catheter (Completed, started 2022-07-18)
- NCT04862689: Investigation of the Ringer Perfusion Balloon Catheter (Ringer PTCA) (Completed, started 2022-05-01)
- NCT03988166: Chronic Total Occlusion Percutaneous Coronary Intervention Study (Completed, started 2020-05-20)
- NCT00652314: Evaluation of an Absorbable Surgical Hemostatic Agent: Thrombi-Gel® Versus Gelfoam-Thrombin (Completed, started 2008-03)
- NCT00565604: Safety and Efficacy of Endovenous Laser Ablation for the Resolution of Incompetent Perforator Veins (Completed, started 2007-10)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Vascular Solutions, Inc. (a text match, not an official crosswalk):
- C9602 — Percutaneous transluminal coronary atherectomy, with drug eluting intracoronary stent, with coronary angioplasty when performed; single major coronary artery or branch (via LOX)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Vascular Technology Incorporated (11 510(k)s)
- Vascular Control Systems, Inc. (9 510(k)s)
- Vascular Architects, Inc. (5 510(k)s)
- Vascular Medcure, Inc. (5 510(k)s)
- Vascular Pathways, Inc. (4 510(k)s)
- Vascular Flow Technologies, Ltd. (3 510(k)s)
- Vascular Products, Inc. (3 510(k)s)
- Vascular Graft Solutions, Ltd. (2 510(k)s)
- Vascular Insights, LLC (2 510(k)s)
- Vascular Designs, Inc. (1 510(k)s)
- Vascular Flow Technologies Limited (1 510(k)s)
- Vascular Intervention (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Vascular Solutions, Inc.?
FDA lists 115 510(k) clearances under the applicant name “Vascular Solutions, Inc.” (first 2002, latest 2024), plus 1 PMA decision, across 18 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Vascular Solutions, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vascular Solutions, Inc. is 79 days. Since 2017: 90 days, versus 105 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Vascular Solutions, Inc.?
The most frequent FDA product codes under this applicant name are DQY (Catheter, Percutaneous, 27); QSX (Hemostatic Wound Dressing With Thrombin Or Other Biologics, 18); GEX (Powered Laser Surgical Instrument, 13).
Next steps
- See all 115 Vascular Solutions, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQY, Vascular Solutions, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.