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

Vas-Cath, Inc. — Predicate Candidate Screening

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

111 daysmedian FDA review time

496 days90th percentile

27clearances measured

K-number	Device	Applicant	Decided	Review days
K973013	OPTI-PLAST (CENTURION) 5.5F ANGIOPLASTY CATHETER	Vas-Cath, Inc.	1998-06-19	310
K965178	NIAGARA DUAL LUMEN CATHETER	Vas-Cath, Inc.	1997-08-19	238
K964881	ULTRAVERSE PTA CATHETER	Vas-Cath, Inc.	1997-05-28	174
K970725	OPTI-PLAST XL 5.5 F PTA CATHETER	Vas-Cath, Inc.	1997-05-09	70
K941706	OPTI-PLAST ANGIOPLASTY CATHETER	Vas-Cath, Inc.	1994-10-18	195
K925485	VAS-CATH INC. OPTI-PLAST ANGIOPLASTY CATHETER	Vas-Cath, Inc.	1994-03-10	496
K933483	OPTI-PLAST 5F PTA CATHETERS	Vas-Cath, Inc.	1993-09-24	86
K914162	VAS-CATH FLEXXICON 2 DUAL LUMEN DIALYSIS CATHETERS	Vas-Cath, Inc.	1993-07-01	653
K914210	VAS-CATH DUALATOR(TM) VESSEL DILATOR	Vas-Cath, Inc.	1993-07-01	651
K914976	OPTI-PLAST 5F PTA CATHETERS, MODIFICATION	Vas-Cath, Inc.	1992-01-27	82
K914500	OPTI-PLAST 5F PTA CATHETERS, MODIFICATION	Vas-Cath, Inc.	1991-12-31	84
K913112	OPTI-PLAST 5F PTA CATHETERS	Vas-Cath, Inc.	1991-08-16	42
K912984	OPTI-PLAST 5F PTA CATHETERS, MODIFICATION	Vas-Cath, Inc.	1991-08-13	46
K911639	OPTI-PLAST 5F PTA CATHETERS OVEN CURING PROCEDURE	Vas-Cath, Inc.	1991-06-11	111
K910996	OPTI-PLAST 5F PTA CATHETERS	Vas-Cath, Inc.	1991-04-09	36
K905505	VAS-CATH URETERAL STENTS CATHETER, MODIFICATION	Vas-Cath, Inc.	1991-04-09	137
K903417	VAS-CATH OPTI-PLAST 5F PERIPHERAL ANGIOPLASTY CATH	Vas-Cath, Inc.	1990-12-05	127
K902367	OPTI-PLAST 7F PERIPHERAL ANGIOPLASTY CATHETER	Vas-Cath, Inc.	1990-12-03	188
K895597	VAS-CATH TRIFUSION TRIPLE LUMEN INFUSION CATHETER	Vas-Cath, Inc.	1990-09-12	359
K895506	FLEXXICON PLUS DUAL LUMEN DIALYSIS CATHETER	Vas-Cath, Inc.	1990-02-09	150
K892926	DUAL LUMEN CATHETER FOR CHRONIC VASCULAR ACCESS	Vas-Cath, Inc.	1989-12-05	228
K894357	VAS-CATH URETERAL STENT CATHETER	Vas-Cath, Inc.	1989-10-03	81
K890099	MODIFIED VAS-CATH CATHETER REPAIR KIT	Vas-Cath, Inc.	1989-04-11	91
K890717	MODIFICATION HEMOFILTRATION CATHETER HF-100	Vas-Cath, Inc.	1989-04-05	51
K883768	VAS-CATH CATHETER REPAIR KIT	Vas-Cath, Inc.	1988-11-14	69
K882466	VAS-CATH PEDIATRIC HEMOFILTRATION CATHETER	Vas-Cath, Inc.	1988-07-13	28
K881743	VAS-CATH FLEXXICON DUAL LUMEN DIALYSIS CATHETER	Vas-Cath, Inc.	1988-06-23	62

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