Precision Vascular Systems, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Precision Vascular Systems, Inc.” (first 1999, latest 2003), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 30 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | 5 | 5 |
| KRA | Catheter, Continuous Flush | 2 | 2 |
Review panels
- Cardiovascular (7)
Most recent Precision Vascular Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K032494 | PVS 1700 STEERABLE DELIVERY SYSTEM MICROCATHETER | KRA | 2003-09-05 | 23 |
| K032146 | PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES | DQX | 2003-08-12 | 29 |
| K023700 | PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIRE | DQX | 2002-12-04 | 30 |
| K020733 | PVS 1500 SDS | KRA | 2002-03-21 | 15 |
| K002907 | PVS 1300 NEURO GUIDE WIRE | DQX | 2001-03-08 | 171 |
| K002707 | PVS 1400 GUIDE WITE WITH HYDROPHILIC COATING | DQX | 2000-11-08 | 70 |
| K990823 | PVS 1400 GUIDEWIRE | DQX | 1999-07-23 | 133 |
Recalls
openFDA lists no recalls under a recalling firm named Precision Vascular Systems, Inc..
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.
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.
- Precision Medical, Inc. (30 510(k)s)
- Precision Dynamics Corp. (26 510(k)s)
- Precision Spine, Inc. (26 510(k)s)
- Precision Biologicals, Inc. (20 510(k)s)
- Precision Biologic (17 510(k)s)
- Precision Med Products, Ltd. (16 510(k)s)
- Precision Acoustics Ind., Inc. (9 510(k)s)
- Precision Cap Systems (7 510(k)s)
- Precision Instruments, Inc. (4 510(k)s)
- Precision Laser Products, Inc. (4 510(k)s)
- Precision Medical Instruments, Inc. (4 510(k)s)
- Precision Therapy Intl., Inc. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Precision Vascular Systems, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Precision Vascular Systems, Inc.” (first 1999, latest 2003), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Precision Vascular Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Precision Vascular Systems, Inc. is 30 days.
Which FDA product codes appear under Precision Vascular Systems, Inc.?
The most frequent FDA product codes under this applicant name are DQX (Wire, Guide, Catheter, 5); KRA (Catheter, Continuous Flush, 2).
Next steps
- See all 7 Precision Vascular Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQX, Precision Vascular Systems, 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.