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

Applied Vascular Devices, Inc. — Predicate Candidate Screening

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

87 daysmedian FDA review time

216 days90th percentile

21clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K911730	SURGICAL OBTURATOR WITH SEAL	Applied Vascular Devices, Inc.	1991-12-23	250	0
K911589	DISPOSABLE SURGICAL TROCAR WITH SEAL	Applied Vascular Devices, Inc.	1991-07-05	87	0
K910339	AVD INTIMAX OCCLUSION CATHETER	Applied Vascular Devices, Inc.	1991-05-29	121	0
K910372	INTIMAX THROMBECTOMY CATHETER	Applied Vascular Devices, Inc.	1991-04-26	87	1
K911181	INTIMAX(TM) IRRIGATION CATHETER	Applied Vascular Devices, Inc.	1991-04-18	31	0
K910493	AVD INTIMAX CHOLANGIOGRAPHY CATHETER	Applied Vascular Devices, Inc.	1991-03-28	51	0
K903848	DIAGNOSTIC INTRASCULAR CATHETER	Applied Vascular Devices, Inc.	1991-03-25	216	0
K905738	OPERATIVE CHOLANGIOGRAPHIC CATHETER	Applied Vascular Devices, Inc.	1991-03-21	87	0
K910079	DISPOSABLE INTRODUCER SHEATH	Applied Vascular Devices, Inc.	1991-02-27	50	0
K902256	IRRIGATION CATHETER 4, 6 AND 10 FRENCH	Applied Vascular Devices, Inc.	1991-02-15	270	1
K904379	SURGICAL TROCAR AND CANNULA	Applied Vascular Devices, Inc.	1990-12-21	87	0
K901627	ARTERIAL EMBOLECTOMY CATHETER	Applied Vascular Devices, Inc.	1990-10-19	193	1
K901628	APPLIED VASCULAR DEVICES 6MM TRACTION CLIP	Applied Vascular Devices, Inc.	1990-07-06	88	0
K901565	ATRAUMAX SURGICAL CLAMP MODEL FOG-5048, 75MM SIDE	Applied Vascular Devices, Inc.	1990-06-12	70	0
K895691	VASCULAR CLAMP	Applied Vascular Devices, Inc.	1989-12-13	83	0
K895214	HEMOSTASIS VALVE	Applied Vascular Devices, Inc.	1989-11-14	88	0
K890766	CATHETER INTRODUCER SHEATH	Applied Vascular Devices, Inc.	1989-09-18	215	0
K891296	ATRAUMAX(TM) SURGICAL CLAMPS	Applied Vascular Devices, Inc.	1989-06-07	86	0
K883790	SURGICAL CLAMP INSERTS	Applied Vascular Devices, Inc.	1988-12-27	111	3
K883909	SURGICAL SPRING CLIPS	Applied Vascular Devices, Inc.	1988-12-27	103	0
K880987	INJECTOR HANDLE WITH SYRINGE	Applied Vascular Devices, Inc.	1988-05-13	66	0

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