Company ยท US
Possis Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 2014. Name variants (Inc, Corp, punctuation) are merged.
34510(k) clearances (0 in 12 months)
4recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| QEZ | Aspiration Thrombectomy Catheter | 19 |
| DTB | Permanent Pacemaker Electrode | 5 |
| DXE | Catheter, Embolectomy | 3 |
| MJN | Catheter, Intravascular Occluding, Temporary | 3 |
| MCW | Catheter, Peripheral, Atherectomy | 2 |
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 1 |
| DTD | Pacemaker Lead Adaptor | 1 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 1 |
| DYF | Prosthesis, Vascular Graft, Of Less Then 6mm Diameter | 1 |
| MCX | Catheter, Coronary, Atherectomy | 1 |
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 14, 2014 | K133629 | ANGIOJET ULTRA AVX THROMBECTOMY SET Possis Medical, Inc. | QEW |
| Jun 22, 2009 | K091593 | ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETS Possis Medical, Inc. | QEZ |
| Apr 8, 2009 | K090253 | ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL 106552-001, ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040-001 Possis Medical, Inc. | QEZ |
| Dec 12, 2008 | K082382 | ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039 Possis Medical, Inc. | QEZ |
| Sep 26, 2008 | K081989 | MODIFICATION TO FETCH ASPIRATION CATHETER Possis Medical, Inc. | QEZ |
| Jun 13, 2008 | K081454 | GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE Possis Medical, Inc. | MJN |
| Apr 4, 2008 | K080806 | ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY SET, MODEL 106608 Possis Medical, Inc. | QEZ |
| Jan 24, 2008 | K073441 | ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039 Possis Medical, Inc. | QEZ |
| Nov 14, 2007 | K072769 | ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553) THROMBECTOMY SETS Possis Medical, Inc. | QEZ |
| Sep 8, 2007 | K072269 | ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL: 106552 Possis Medical, Inc. | QEZ |
| Aug 24, 2007 | K071336 | ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307 Possis Medical, Inc. | QEZ |
| Jul 31, 2007 | K071514 | ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307 Possis Medical, Inc. | QEZ |
| Jul 31, 2007 | K071342 | ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040, 105042, 106552, 105043, 105041, 106553, 105039 Possis Medical, Inc. | QEZ |
| May 11, 2007 | K070363 | FETCH ASPIRATION CATHETER Possis Medical, Inc. | QEZ |
| Nov 22, 2006 | K061951 | ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL XPEEDIOR 120 Possis Medical, Inc. | QEZ |
| Sep 20, 2006 | K062172 | FETCH ASPIRATION CATHETER Possis Medical, Inc. | QEZ |
| Aug 11, 2006 | K062220 | MODIFICATION TO GUARDDOG OCCLUSION SYSTEM Possis Medical, Inc. | MJN |
| Nov 10, 2005 | K052256 | ANGIOJET XPEEDIOR 120 CATHETER Possis Medical, Inc. | QEZ |
| Apr 28, 2005 | K050794 | ANGIOJET DVX RHEOLYTIC THROMBECTOMY CATHETER Possis Medical, Inc. | QEZ |
| Nov 5, 2004 | K042874 | ANGIOJET XMI CATHETER - RAPID EXCHANGE (XMI-RX) Possis Medical, Inc. | QEZ |
| May 18, 2004 | K040013 | ANGIOJET XPEEDIOR 120 CATHETER AND ANGIOJET POWER PULSE SPRAY ANCILLARY KIT Possis Medical, Inc. | QEZ |
| May 18, 2004 | K031357 | GUARDDOG OCCLUSION SYSTEM, OCCLUSION GUIDEWIRE, 300 CM, GUARDDOG OCCLUSION SYSTEM OCCLUSION GUIDEWIRE, 200 CM Possis Medical, Inc. | MJN |
| Apr 28, 2000 | K993564 | POSSIS ANGIOJET X-STREAM RHEOLYTIC THROMBECTOMY CATHETER, MODEL 103587-002 Possis Medical, Inc. | MCW |
| Apr 11, 2000 | K972610 | POSSIS ANGIOJET RAPID THOMBECTOMY CATHETERS--F105 CATHETER MODEL 3030C, LF140 CATHETER MODEL 3040C Possis Medical, Inc. | QEZ |
| Feb 1, 1999 | K984183 | PERMA-PASS VASCULAR GRAFT, 5T GRAFT,MODEL 31451 Possis Medical, Inc. | DYF |
| Feb 1, 1999 | K984182 | PERMA-PASS VASCULAR GRAFT, 6S GRAFT,MODEL 31453, 6T GRAFT,MODEL 31452 Possis Medical, Inc. | DSY |
| Dec 3, 1996 | K960970 | POSSIS ANGIOJET RAPID THROMBECTOMY CATHETER SYSTEM, F105 CATHETER,MODEL 3030C,LF140 CATHETER,MODEL 3040C,PUMP SET 3020P Possis Medical, Inc. | MCW |
| Jun 22, 1993 | K925099 | POSSIS MEDICAL MYOPORE BIPOLAR SUTURELESS MYCARDIA Possis Medical, Inc. | DTB |
| Aug 9, 1991 | K910528 | BIPOLAR SUTURELESS MYOCARDIAL PACING LEADS Possis Medical, Inc. | DTB |
| Mar 6, 1990 | K900605 | 3.2-5MM UNIPOLAR LEAD UPSIZING KIT, MODEL AK 100 Possis Medical, Inc. | DTD |
| Dec 20, 1989 | K896443 | MYOPORE(TM) UNIPOLAR MODELS 1117 & 1118 PACE LEADS Possis Medical, Inc. | DTB |
| Jul 14, 1989 | K893763 | MODELS 1113 AND 1114 PACEMAKER LEADS Possis Medical, Inc. | DTB |
| Jul 14, 1989 | K885175 | MYOPORE(TM) UNIPOLAR SUTURELESS MYOCARDIAL LEADS Possis Medical, Inc. | DTB |
| Aug 10, 1983 | K831330 | UNIVERSAL CORONARY CANNULA Possis Medical, Inc. | DWF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 10, 2007 | Possis Medical, Inc Possis AngioJet XVG Thrombectomy Sets,
Model/Order # 105042-001, Sterilized with Ethylene Oxide,
Possis Medical, Inc., 9055 Evergreen Boulevard NW, Minneapolis, MN 55433-8003. (These sets are used wit Terminated |
DXE | K050794 |
| Jun 21, 2007 | Possis Medical, Inc Angiojet XMI Rapid Exchange, catheters, 135 cm, 4 F, Single Use Only, Sterilized with Ethylene Oxide, POSSIS MEDICAL, INC. 9055 Evergreen Boulevard NW Minneapolis, MN 55433-8003 USA-- (XMI - Rapid E Terminated |
DXE | K042874 |
| Jun 21, 2007 | Possis Medical, Inc Angiojet Spiroflex, Catheter, 135 cm, 4F, Single use only, Sterilized with Ethylene Oxide, POSSIS MEDICAL, INC. 9055 Evergreen Boulevard NW Minneapolis, MN 55433-8003 USA-
(Spiroflex Rheolytic Thromb Terminated |
MCX | None listed |
| Feb 4, 2006 | Possis Medical, Inc AngioJet XMI Rapid Exchange +, 4F, 135 cm. Contents: One (1) Thrombectomy Catheter for Peripheral Use. Sterilized with Ethylene Oxide. Single Use Only. Manufactured and Distributed by: Possis M Terminated |
DXE | K042874 |