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

Cordis Corporation · Predicate Candidate Screening

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

83 daysmedian FDA review time

191 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K220654	ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli	Cordis Corporation	2022-04-06	30	14
K212977	SUPER TORQUE MB Angiographic Catheter with Radiopaque marker	Cordis Corporation	2022-02-17	153	0
K210626	SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilat	Cordis Corporation	2021-04-23	52	0
K202167	Brite Tip Radianz Guiding Sheath	Cordis Corporation	2021-02-26	207	0
K201377	SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatat	Cordis Corporation	2020-10-09	136	0
K201333	SABER .035 PTA Dilatation Catheter	Cordis Corporation	2020-09-11	115	0
K181592	RAIN Sheath Transradial	Cordis Corporation	2018-08-15	58	0
K180081	RAILWAY Sheathless Access System	Cordis Corporation	2018-04-18	97	0
K143412	ADROIT Guiding Catheter	Cordis Corporation	2015-01-14	47	0
K133843	SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHE	Cordis Corporation	2014-06-27	191	0
K121442	POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER	Cordis Corporation	2012-06-14	30	1
K041796	PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM	Cordis Corporation	2004-08-03	32	0
K034050	CORDIS OPTEASE VENA CAVA FILTER, MODELS 466-F220A AND 466-F2	Cordis Corporation	2004-03-22	83	1

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