Atlas FDA

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

Cryo Vascular Systems, Inc. — Predicate Candidate Screening

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

84 daysmedian FDA review time
172 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K051916POLAR CATH PERIPHERAL DILATATION SYSTEMCryo Vascular Systems, Inc.2005-08-05210
K042230POLARCATH PERIPHERAL BALLOON CATHETER SYSTEMCryo Vascular Systems, Inc.2004-11-05800
K042541MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEMCryo Vascular Systems, Inc.2004-10-12220
K033622POLARCATH PERIPHERAL DILATATION SYSTEMCryo Vascular Systems, Inc.2004-02-10840
K030742POLARCATH PERIPHERAL BALLOON CATHETER SYSTEMCryo Vascular Systems, Inc.2003-08-291720
K023463CVSI PERIPHERAL BALLOON CATHETER; CVSI CATHETER INFLATION UNCryo Vascular Systems, Inc.2003-02-191270
K022061CVSI PERIPHERAL BALLOON CATHETER; CVSI INFLATERCryo Vascular Systems, Inc.2002-09-20870

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