Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Devices For Vascular Intervention, Inc. — Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
77 daysmedian FDA review time
92 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K935929 | MICROTRACK | Devices For Vascular Intervention, Inc. | 1994-03-10 | 87 | 0 |
| K920707 | HOLLOW MOTOR DRIVE UNIT W/ TORQUE CONTROLLER | Devices For Vascular Intervention, Inc. | 1992-11-23 | 279 | 0 |
| K914422 | DEVICES FOR VASCU INTERVENT ROTAT HEMOSTAT VALVE | Devices For Vascular Intervention, Inc. | 1991-12-18 | 76 | 0 |
| K911678 | ROTATING HEMOSTATIC VALVE | Devices For Vascular Intervention, Inc. | 1991-07-12 | 88 | 0 |
| K910205 | LP-60 LOW PRESSURE INFLATION DEVICE | Devices For Vascular Intervention, Inc. | 1991-02-25 | 40 | 0 |
| K901601 | HOLLOW MOTOR DRIVE UNIT | Devices For Vascular Intervention, Inc. | 1990-07-06 | 91 | 0 |
| K883933 | INTRODUCING CATHETER | Devices For Vascular Intervention, Inc. | 1988-12-02 | 78 | 0 |
| K883981 | GUIDING CATHETER (TIP SOFTNESS CHANGE) | Devices For Vascular Intervention, Inc. | 1988-11-03 | 43 | 0 |
| K883916 | ROTATING HEMOSTATIC VALVE | Devices For Vascular Intervention, Inc. | 1988-10-28 | 42 | 0 |
| K883346 | SIMPSON PERIPHERAL ATHEROCATH W/ADDIT. SIZE 13F | Devices For Vascular Intervention, Inc. | 1988-09-26 | 60 | 0 |
| K881088 | ADDITION OF A TIP GUARD TO THE ATHEROCATH(TM) | Devices For Vascular Intervention, Inc. | 1988-05-31 | 77 | 0 |
| K874706 | MODIFIED SIMPSON PERIPHERAL ATHEROCATH | Devices For Vascular Intervention, Inc. | 1988-01-04 | 61 | 0 |
| K871021 | GUIDING CATHETERS 9F JL4 | Devices For Vascular Intervention, Inc. | 1987-06-16 | 92 | 0 |
| K871011 | SIMPSON PERIPHERAL ATHEROCATH(TM) | Devices For Vascular Intervention, Inc. | 1987-05-14 | 62 | 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