Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Intervalve, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
80 daysmedian FDA review time
137 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K152150 | V8 Balloon Aortic Valvuloplasty Catheter | Intervalve, Inc. | 2015-12-18 | 137 | 0 |
| K150343 | V8 Transluminal BAV Catheter | Intervalve, Inc. | 2015-04-03 | 51 | 0 |
| K133607 | V8 TRANSLUMINAL BAV CATHETER | Intervalve, Inc. | 2014-02-11 | 78 | 1 |
| K132728 | V8 TRANSLUMINAL BAV CATHETER | Intervalve, Inc. | 2013-11-22 | 80 | 0 |
| K123111 | V8 TRANSLUMINAL BAV CATHETER | Intervalve, Inc. | 2013-01-31 | 120 | 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