Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Medical Cv, Inc. — Predicate Candidate Screening

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

252 daysmedian FDA review time
289 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K081457ATRILAZE LASER ABLATION SYSTEMMedical Cv, Inc.2008-08-08770
K061489ATRILAZE MI SURGICAL ABLATION SYSTEMMedical Cv, Inc.2007-03-162890
K060680ATRILAZE SURGICAL ABLATION SYSTEMMedical Cv, Inc.2006-04-11270
K052495ATRILAZE MALLEABLE ABLATION PROBEMedical Cv, Inc.2005-10-11290
K040744ATRILAZE SOFT TISSUE ABLATION SYSTEMMedical Cv, Inc.2004-11-302520
K033685NORTHRUP UNIVERSAL ANNULOPLASTY SYSTEM, MODEL 1000Medical Cv, Inc.2004-08-032530

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