Possis Medical, Inc.
Minneapolis, MN, US
Possis Medical, Inc. appears in FDA device records in Minneapolis, MN. FDA records list 34 510(k) clearances between and , 2 PMA records and no registered establishments. As of , FDA records show 4 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 34 510(k) clearances for Possis Medical, Inc. between 1983 and 2014. The busiest year on record is 2007, with 6. The most recent is 2014, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 1 |
| 1989 | 3 |
| 1990 | 1 |
| 1991 | 1 |
| 1993 | 1 |
| 1996 | 1 |
| 1999 | 2 |
| 2000 | 2 |
| 2004 | 3 |
| 2005 | 2 |
| 2006 | 3 |
| 2007 | 6 |
| 2008 | 5 |
| 2009 | 2 |
| 2014 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K133629 | ANGIOJET ULTRA AVX THROMBECTOMY SET | QEW | Substantially Equivalent | |
| K091593 | ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETS | QEZ | Substantially Equivalent | |
| K090253 | ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL 106552-001, ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040-001 | QEZ | Substantially Equivalent | |
| K082382 | ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039 | QEZ | Substantially Equivalent | |
| K081989 | MODIFICATION TO FETCH ASPIRATION CATHETER | QEZ | Substantially Equivalent | |
| K081454 | GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE | MJN | Substantially Equivalent | |
| K080806 | ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY SET, MODEL 106608 | QEZ | Substantially Equivalent | |
| K073441 | ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039 | QEZ | Substantially Equivalent | |
| K072769 | ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553) THROMBECTOMY SETS | QEZ | Substantially Equivalent | |
| K072269 | ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL: 106552 | QEZ | Substantially Equivalent | |
| K071336 | ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307 | QEZ | Substantially Equivalent | |
| K071514 | ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307 | QEZ | Substantially Equivalent | |
| K071342 | ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040, 105042, 106552, 105043, 105041, 106553, 105039 | QEZ | Substantially Equivalent | |
| K070363 | FETCH ASPIRATION CATHETER | QEZ | Substantially Equivalent | |
| K061951 | ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL XPEEDIOR 120 | QEZ | Substantially Equivalent | |
| K062172 | FETCH ASPIRATION CATHETER | QEZ | Substantially Equivalent | |
| K062220 | MODIFICATION TO GUARDDOG OCCLUSION SYSTEM | MJN | Substantially Equivalent | |
| K052256 | ANGIOJET XPEEDIOR 120 CATHETER | QEZ | Substantially Equivalent | |
| K050794 | ANGIOJET DVX RHEOLYTIC THROMBECTOMY CATHETER | QEZ | Substantially Equivalent | |
| K042874 | ANGIOJET XMI CATHETER - RAPID EXCHANGE (XMI-RX) | QEZ | Substantially Equivalent | |
| K040013 | ANGIOJET XPEEDIOR 120 CATHETER AND ANGIOJET POWER PULSE SPRAY ANCILLARY KIT | QEZ | Substantially Equivalent | |
| K031357 | GUARDDOG OCCLUSION SYSTEM, OCCLUSION GUIDEWIRE, 300 CM, GUARDDOG OCCLUSION SYSTEM OCCLUSION GUIDEWIRE, 200 CM | MJN | Substantially Equivalent | |
| K993564 | POSSIS ANGIOJET X-STREAM RHEOLYTIC THROMBECTOMY CATHETER, MODEL 103587-002 | MCW | Substantially Equivalent | |
| K972610 | POSSIS ANGIOJET RAPID THOMBECTOMY CATHETERS--F105 CATHETER MODEL 3030C, LF140 CATHETER MODEL 3040C | QEZ | Substantially Equivalent | |
| K984183 | PERMA-PASS VASCULAR GRAFT, 5T GRAFT,MODEL 31451 | DYF | Substantially Equivalent | |
| K984182 | PERMA-PASS VASCULAR GRAFT, 6S GRAFT,MODEL 31453, 6T GRAFT,MODEL 31452 | DSY | Substantially Equivalent | |
| K960970 | POSSIS ANGIOJET RAPID THROMBECTOMY CATHETER SYSTEM, F105 CATHETER,MODEL 3030C,LF140 CATHETER,MODEL 3040C,PUMP SET 3020P | MCW | Substantially Equivalent | |
| K925099 | POSSIS MEDICAL MYOPORE BIPOLAR SUTURELESS MYCARDIA | DTB | Substantially Equivalent | |
| K910528 | BIPOLAR SUTURELESS MYOCARDIAL PACING LEADS | DTB | Substantially Equivalent | |
| K900605 | 3.2-5MM UNIPOLAR LEAD UPSIZING KIT, MODEL AK 100 | DTD | Substantially Equivalent | |
| K896443 | MYOPORE(TM) UNIPOLAR MODELS 1117 & 1118 PACE LEADS | DTB | Substantially Equivalent | |
| K893763 | MODELS 1113 AND 1114 PACEMAKER LEADS | DTB | Substantially Equivalent | |
| K885175 | MYOPORE(TM) UNIPOLAR SUTURELESS MYOCARDIAL LEADS | DTB | Substantially Equivalent | |
| K831330 | UNIVERSAL CORONARY CANNULA | DWF | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- QEZAspiration Thrombectomy Catheter
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- MJNCatheter, Intravascular Occluding, Temporary
- MCWCatheter, Peripheral, Atherectomy
- DTDPacemaker Lead Adaptor
- QEWPeripheral Mechanical Thrombectomy With Aspiration
- DTBPermanent Pacemaker Electrode
- DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter
- DYFProsthesis, Vascular Graft, Of Less Then 6mm Diameter
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1131-2007 | 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 with the new AngioJet Ultra Console) | Mislabeling : Possis AngioJet XVG Catheter Thrombectomy Sets display incorrect information on the outer packaging box and also on the inner sterile tray. The labeling incorrectly states that the unit is indicated for use in coronary vessels. These units should indicated use only for peripheral arteries. | Terminated | ||
| Z-0955-2007 | 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 Exchange Rheolytic Thrombectomy Catheter) is one component of the AngioJet Rheolytic Thrombectomy System (AngioJet System). | Mislabeling: XMI (OTW) catheters were mislabeled as XMI-RX units and AVX catheters were mislabeled as Spiroflex catheters. | Terminated | ||
| Z-0954-2007 | 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 Thrombectomy Catheter) is one component of the AngioJet Rheolytic Thrombectomy System (AngioJet System). | Mislabeling: XMI (OTW) catheters were mislabeled as XMI-RX units and AVX catheters were mislabeled as Spiroflex catheters. | Terminated | ||
| Z-0469-06 | 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 Medical, Inc. 9055 Evergreen Boulevard NW, Minneapolis, MN 55433-8003 USA. | It was reported that the catheter model inside the product tray and box was not an XMI RX Plus, but an XMI over-the-wire model. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain