Precision Vascular Systems, Inc.: FDA clearances and approvals
Precision Vascular Systems, Inc. has 7 FDA 510(k) clearances (first 1999, latest 2003), across 2 product codes in 1 review panel. Median 510(k) review time: 30 days.
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 company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Precision Vascular Systems, Inc. have?
Precision Vascular Systems, Inc. has 7 FDA 510(k) clearances (first 1999, latest 2003), across 2 product codes in 1 review panel.
How long does FDA take to clear Precision Vascular Systems, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Precision Vascular Systems, Inc.'s cleared 510(k)s is 30 days.
What devices does Precision Vascular Systems, Inc. make?
Its most frequent FDA product codes are DQX (Wire, Guide, Catheter, 5); KRA (Catheter, Continuous Flush, 2).
Has Precision Vascular Systems, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Precision Vascular Systems, Inc. Related entities may recall under other names.
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. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.