Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Cardiva Medical, Inc. · Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

135 daysmedian FDA review time
519 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K130124CATALYST II AND IIICardiva Medical, Inc.2013-03-14560
K082930CARDIVA CATALYST III SYSTEM WITH PROTAMINE SULFATECardiva Medical, Inc.2009-02-131350
K072297BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEMCardiva Medical, Inc.2007-09-12260
K070485BOOMERANG WIRE /BOOMERANG PLUS WIRE SYSTEM, MODEL# B PLUS WICardiva Medical, Inc.2007-03-22300
K051817BOOMERANG CLOSUREWIRE VASCULAR CLOSURE SYSTEMCardiva Medical, Inc.2006-12-065190
K061075BOOMERANG WIRECardiva Medical, Inc.2006-09-011370
K041486VASOSTASIS VASCULAR CLOSURE SYSTEMCardiva Medical, Inc.2004-10-221400

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