Atlas FDA

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

William Cook Europe Aps — Predicate Candidate Screening

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

84 daysmedian FDA review time
297 days90th percentile
18clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K251596Lunderquist Extra Stiff Wire GuideWilliam Cook Europe Aps2025-11-091660
K251499Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova IntubWilliam Cook Europe Aps2025-06-11270
K233680Celect Platinum Vena Cava Filter Set for Femoral Vein ApproaWilliam Cook Europe Aps2024-01-18630
K220137Lunderquist Extra Stiff Wire GuideWilliam Cook Europe Aps2022-02-17300
K211874Günther Tulip Vena Cava Filter Set for Femoral Vein ApproachWilliam Cook Europe Aps2021-07-28410
K211875Cook Celect Platinum Vena Cava Filter Set for Femoral Vein AWilliam Cook Europe Aps2021-07-28410
K171513Lunderquist Extra Stiff Wire GuideWilliam Cook Europe Aps2017-12-071970
K172557Gunther Tulip Vena Cava Filter Set for Femoral Vein ApproachWilliam Cook Europe Aps2017-11-20880
K172584Günther Tulip Vena Cava Filter Set for Femoral Vein ApproachWilliam Cook Europe Aps2017-11-20840
K171712Cook Celect Platinum Vena Cava Filter Set for Femoral Vein AWilliam Cook Europe Aps2017-08-07590
K161813Frova Intubating IntroducerWilliam Cook Europe Aps2017-05-193220
K121629COOK CELECT PLATINUM VENA CAVA FILTER SET FOR FEMORAL APPROAWilliam Cook Europe Aps2012-07-03290
K121057COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETSWilliam Cook Europe Aps2012-05-04280
K112119CUNTHER TULIP(R) VENA CAVA FILTER SET FOR FEMORAL APPROACH, William Cook Europe Aps2012-03-302490
K090140GUNTHER TULIP VENA CAVA FILTER, COOK CELECT VENA CAVA FILTERWilliam Cook Europe Aps2009-04-03720
K073374COOK CLECT VENA CAVA FILTER, GUNTHER TULIP VENA CAVA FILTER William Cook Europe Aps2008-03-07950
K061815COOK CELECT VENA CAVA FILTERWilliam Cook Europe Aps2007-04-202970
K061670LUNDERQUIST WIRE GUIDE; DC WIRE GUIDEWilliam Cook Europe Aps2007-01-192190

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