Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Microvena Corp. — Predicate Candidate Screening
18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
174 daysmedian FDA review time
434 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K991898 | ULTRA-SELECT GUIDEWIRE, HYTEK GUIDEWIRE | Microvena Corp. | 1999-06-16 | 12 | 0 |
| K991194 | MODIFICATION TO ULTRA-SELECT GUIDEWIRE | Microvena Corp. | 1999-05-05 | 27 | 0 |
| K982657 | AMPLATZ THROMBECTOMY DEVICE MODELS ATD 601, ATD 602, ATD 801 | Microvena Corp. | 1998-11-18 | 111 | 0 |
| K970668 | THE AMPLANTZ GOOSE NECK MICROSNARE | Microvena Corp. | 1998-06-10 | 471 | 0 |
| K972511 | AMPLATZ GOOSE NECK SNARE KIT/ CATHETER | Microvena Corp. | 1998-03-06 | 246 | 1 |
| K971984 | AMPLATZ THROMBECTOMY DEVICE(ATD 603,602,801,802)/FOOT PEDAL | Microvena Corp. | 1997-09-19 | 113 | 0 |
| K954642 | HYDRO-SELECT GUIDEWIRE | Microvena Corp. | 1996-12-17 | 434 | 0 |
| K954205 | THE AMPLATZ THROMBECTOMY DEVICE | Microvena Corp. | 1996-08-13 | 341 | 0 |
| K955304 | CRICKET | Microvena Corp. | 1996-05-16 | 178 | 0 |
| K952860 | THE NINER NITINOL GUIDEWIRE | Microvena Corp. | 1995-12-13 | 174 | 0 |
| K946356 | M-PATH NITINOL GUIDEWIRE | Microvena Corp. | 1995-03-31 | 91 | 0 |
| K925439 | MICROSNARE | Microvena Corp. | 1993-09-24 | 331 | 0 |
| K922060 | .25' ULTRA-SELECT GUIDEWIRE | Microvena Corp. | 1993-02-23 | 295 | 0 |
| K914046 | THE BIG EASY Y-ADAPTER | Microvena Corp. | 1991-11-08 | 59 | 0 |
| K910280 | ULTRA-SELECT PTCA GUIDEWIRE | Microvena Corp. | 1991-04-19 | 86 | 0 |
| K901502 | AMPLATZ GOOSE-NECK SNARE | Microvena Corp. | 1990-12-03 | 249 | 1 |
| K900657 | UNIVERSAL DELIVERY SYSTEM CATHETER | Microvena Corp. | 1990-05-09 | 89 | 0 |
| K896096 | SOLOSTICK (AMPLATZ DILATOR NEEDLE) | Microvena Corp. | 1990-04-10 | 172 | 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