Vascular Technology Incorporated: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Vascular Technology Incorporated” (first 1985, latest 2008), across 7 product codes in 4 review panels. Median 510(k) review time under this name: 42 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 |
|---|---|---|---|
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 4 | 4 |
| DPW | Flowmeter, Blood, Cardiovascular | 2 | 2 |
| CBZ | Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling | 1 | 1 |
| DQK | Computer, Diagnostic, Programmable | 1 | 1 |
| DXS | Gauge, Pressure, Coronary, Cardiopulmonary Bypass | 1 | 1 |
| FFT | Electrode, Ph, Stomach | 1 | 1 |
| HBL | Holder, Head, Neurosurgical (Skull Clamp) | 1 | 1 |
Review panels
Most recent Vascular Technology Incorporated 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K082870 | VTI INTRAOPERATIVE DOPPLER SYSTEMS | DPW | 2008-10-28 | 29 |
| K031091 | VTI 20 MHZ GATED DOPPLER | DPW | 2003-04-23 | 16 |
| K002990 | VTI ADULT DISPOSABLE SKULL PIN, MODEL 22000; VTI SKULL SCREW, MODEL 22001 | HBL | 2000-11-06 | 42 |
| K944764 | VTI DISPOSABLE PRESSURE DISPLAY SET | DXS | 1994-12-27 | 91 |
| K922738 | VTI OXYGEN ANALYZER | CCL | 1993-01-27 | 233 |
| K890058 | VASCULAR TECHNOLOGY UNIOX OXYGEN ALARM | CCL | 1989-11-21 | 319 |
| K883960 | GIPHY MONITOR | FFT | 1989-10-04 | 379 |
| K864583 | CARDIAC PERFORMANCE MONITOR | DQK | 1987-05-11 | 172 |
| K862114 | KHURI REGIONAL TISSUE PH MONITOR | CBZ | 1986-06-25 | 22 |
| K862113 | NO. 100352 GALVANIC OXYGEN SENSOR | CCL | 1986-06-19 | 16 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Vascular Technology Incorporated.
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.
- Vascular Solutions, Inc. (115 510(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 Technology Incorporated?
FDA lists 11 510(k) clearances under the applicant name “Vascular Technology Incorporated” (first 1985, latest 2008), across 7 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 Technology Incorporated?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vascular Technology Incorporated is 42 days.
Which FDA product codes appear under Vascular Technology Incorporated?
The most frequent FDA product codes under this applicant name are CCL (Analyzer, Gas, Oxygen, Gaseous-Phase, 4); DPW (Flowmeter, Blood, Cardiovascular, 2); CBZ (Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling, 1).
Next steps
- See all 11 Vascular Technology Incorporated clearances with predicates and recalls
- Run predicate analysis for product code CCL, Vascular Technology Incorporated'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.