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

Medtronics Interventional Vascular — Predicate Candidate Screening

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

161 daysmedian FDA review time

230 days90th percentile

21clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K990707	MEDTRONIC 5F & 9F ZUMA GUIDING CATHETERS	Medtronics Interventional Vascular	1999-03-22	18	4
K980973	MEDTRONIC ANGIOGRAPHIC CATHETER	Medtronics Interventional Vascular	1998-12-10	269	0
K982883	MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER	Medtronics Interventional Vascular	1998-09-04	18	10
K981198	MEDTRONIC ZUMA GUIDING CATHETER	Medtronics Interventional Vascular	1998-08-07	127	25
K972944	MEDTRONIC MUSTANG SUPER FLOPPY GUIDE WIRE/FLOPPY GUIDE WIRE/	Medtronics Interventional Vascular	1997-11-03	84	0
K961917	MEDTRONIC MUSTANG STEERABLE GUIDE WIRE (M-45FR, M45FX)	Medtronics Interventional Vascular	1996-11-20	187	0
K960983	MEDTRONIC EVERST 30 INFLATION DEVICE/SURVIVAL KIT	Medtronics Interventional Vascular	1996-05-30	80	3
K955651	MEDTRONIC SHERPA GUIDING CATHETER	Medtronics Interventional Vascular	1996-01-22	41	0
K950490	MEDTRONIC GC IV CORONARY GUIDING CATHETER	Medtronics Interventional Vascular	1995-11-21	288	0
K950179	MEDTRONIC(R) GC III CORONARY GUIDING CATHETER	Medtronics Interventional Vascular	1995-07-25	189	0
K950026	MEDTRONIC(R) 8.2 FRENCH SHERPA(R) SUPER PEAK FLOW(TM) CORONA	Medtronics Interventional Vascular	1995-04-05	91	0
K944668	SHERPA SHERPA II AND ASCENT CORONARY GUIDING CATHETERS	Medtronics Interventional Vascular	1995-03-03	171	0
K945461	PITON(TM) Y-PACK AND PITON(TM) TRI-PACK)	Medtronics Interventional Vascular	1995-02-03	88	0
K942269	MEDTRONIC EVEREST INFLATION DEVICE	Medtronics Interventional Vascular	1994-10-18	161	5
K935738	MEDTRONIC GCIII CORONARY GUIDING CATHETER	Medtronics Interventional Vascular	1994-05-04	154	0
K935425	METRONIC BUCHBINDER ENVOY PERCUTANEOUS CATHETERS	Medtronics Interventional Vascular	1994-04-26	167	0
K940063	MEDTRONIC INTERVENTIONAL VASCULAR Y-ADAPTER, TRI-ADAPTER, TR	Medtronics Interventional Vascular	1994-03-29	82	0
K932933	GC IV CORONARY GUIDING CATHETER	Medtronics Interventional Vascular	1994-02-01	230	0
K925342	MEDTRONIC INTERVENTIONAL VASCULAR SHERPA GUIDEWIRE	Medtronics Interventional Vascular	1993-05-06	198	0
K923638	ACESSORY PACK	Medtronics Interventional Vascular	1993-02-08	202	0
K915351	SHERPA GUIDING CATHETER WITH CATHETER INTRODUCER	Medtronics Interventional Vascular	1992-06-29	216	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