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

Possis Medical, Inc. · Predicate Candidate Screening

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

74 daysmedian FDA review time

257 days90th percentile

34clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K133629	ANGIOJET ULTRA AVX THROMBECTOMY SET	Possis Medical, Inc.	2014-02-14	80	1
K091593	ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETS	Possis Medical, Inc.	2009-06-22	20	0
K090253	ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL 106552-001, ANGIO	Possis Medical, Inc.	2009-04-08	65	0
K082382	ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039	Possis Medical, Inc.	2008-12-12	115	0
K081989	MODIFICATION TO FETCH ASPIRATION CATHETER	Possis Medical, Inc.	2008-09-26	74	0
K081454	GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE	Possis Medical, Inc.	2008-06-13	21	0
K080806	ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY SET, MODEL 106608	Possis Medical, Inc.	2008-04-04	14	0
K073441	ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039	Possis Medical, Inc.	2008-01-24	48	0
K072769	ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (10	Possis Medical, Inc.	2007-11-14	47	1
K072269	ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL: 106552	Possis Medical, Inc.	2007-09-08	24	0
K071336	ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104	Possis Medical, Inc.	2007-08-24	105	0
K071342	ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040, 1050	Possis Medical, Inc.	2007-07-31	78	0
K071514	ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104	Possis Medical, Inc.	2007-07-31	57	0
K070363	FETCH ASPIRATION CATHETER	Possis Medical, Inc.	2007-05-11	93	0
K061951	ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL XPE	Possis Medical, Inc.	2006-11-22	135	0
K062172	FETCH ASPIRATION CATHETER	Possis Medical, Inc.	2006-09-20	51	0
K062220	MODIFICATION TO GUARDDOG OCCLUSION SYSTEM	Possis Medical, Inc.	2006-08-11	9	0
K052256	ANGIOJET XPEEDIOR 120 CATHETER	Possis Medical, Inc.	2005-11-10	84	0
K050794	ANGIOJET DVX RHEOLYTIC THROMBECTOMY CATHETER	Possis Medical, Inc.	2005-04-28	30	1
K042874	ANGIOJET XMI CATHETER - RAPID EXCHANGE (XMI-RX)	Possis Medical, Inc.	2004-11-05	18	2
K040013	ANGIOJET XPEEDIOR 120 CATHETER AND ANGIOJET POWER PULSE SPRA	Possis Medical, Inc.	2004-05-18	134	0
K031357	GUARDDOG OCCLUSION SYSTEM, OCCLUSION GUIDEWIRE, 300 CM, GUAR	Possis Medical, Inc.	2004-05-18	384	0
K993564	POSSIS ANGIOJET X-STREAM RHEOLYTIC THROMBECTOMY CATHETER, MO	Possis Medical, Inc.	2000-04-28	190	0
K972610	POSSIS ANGIOJET RAPID THOMBECTOMY CATHETERS--F105 CATHETER M	Possis Medical, Inc.	2000-04-11	1002	0
K984182	PERMA-PASS VASCULAR GRAFT, 6S GRAFT,MODEL 31453, 6T GRAFT,MO	Possis Medical, Inc.	1999-02-01	70	0
K984183	PERMA-PASS VASCULAR GRAFT, 5T GRAFT,MODEL 31451	Possis Medical, Inc.	1999-02-01	70	0
K960970	POSSIS ANGIOJET RAPID THROMBECTOMY CATHETER SYSTEM, F105 CAT	Possis Medical, Inc.	1996-12-03	267	0
K925099	POSSIS MEDICAL MYOPORE BIPOLAR SUTURELESS MYCARDIA	Possis Medical, Inc.	1993-06-22	257	1
K910528	BIPOLAR SUTURELESS MYOCARDIAL PACING LEADS	Possis Medical, Inc.	1991-08-09	182	0
K900605	3.2-5MM UNIPOLAR LEAD UPSIZING KIT, MODEL AK 100	Possis Medical, Inc.	1990-03-06	26	0
K896443	MYOPORE(TM) UNIPOLAR MODELS 1117 & 1118 PACE LEADS	Possis Medical, Inc.	1989-12-20	41	0
K893763	MODELS 1113 AND 1114 PACEMAKER LEADS	Possis Medical, Inc.	1989-07-14	56	0
K885175	MYOPORE(TM) UNIPOLAR SUTURELESS MYOCARDIAL LEADS	Possis Medical, Inc.	1989-07-14	212	0
K831330	UNIVERSAL CORONARY CANNULA	Possis Medical, Inc.	1983-08-10	107	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