Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Precision Vascular Systems, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
30 daysmedian FDA review time
171 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K032494 | PVS 1700 STEERABLE DELIVERY SYSTEM MICROCATHETER | Precision Vascular Systems, Inc. | 2003-09-05 | 23 | 0 |
| K032146 | PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES | Precision Vascular Systems, Inc. | 2003-08-12 | 29 | 1 |
| K023700 | PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIRE | Precision Vascular Systems, Inc. | 2002-12-04 | 30 | 1 |
| K020733 | PVS 1500 SDS | Precision Vascular Systems, Inc. | 2002-03-21 | 15 | 0 |
| K002907 | PVS 1300 NEURO GUIDE WIRE | Precision Vascular Systems, Inc. | 2001-03-08 | 171 | 1 |
| K002707 | PVS 1400 GUIDE WITE WITH HYDROPHILIC COATING | Precision Vascular Systems, Inc. | 2000-11-08 | 70 | 0 |
| K990823 | PVS 1400 GUIDEWIRE | Precision Vascular Systems, Inc. | 1999-07-23 | 133 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda