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

Cook Vascular, Inc. — Predicate Candidate Screening

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

129 daysmedian FDA review time
452 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K142301Evolution Mechanical Dilator Sheath Set, Evolution Shortie MCook Vascular, Inc.2014-11-12860
K141148EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, EVOLUTICook Vascular, Inc.2014-07-01570
K110347DOPPLER MONITORCook Vascular, Inc.2011-03-16370
K083482COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SECook Vascular, Inc.2009-04-021290
K081425COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER ICook Vascular, Inc.2008-09-301320
K061000EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LCook Vascular, Inc.2006-05-10290
K032223COOK VASCULAR PERFECTA ELECTROSURGICAL DISSECTION SYSTEM ERGCook Vascular, Inc.2003-10-15860
K023937COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEMCook Vascular, Inc.2003-05-271820
K022649COOK-SWARTZ DOPPLER FLOW PROBECook Vascular, Inc.2002-09-06280
K010128COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVECook Vascular, Inc.2002-04-254640
K002958SHAPEABLE DOPPLER FLOW PROBECook Vascular, Inc.2001-12-184520
K010055COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATHCook Vascular, Inc.2001-06-141570

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