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Possis Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
34
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K133629ANGIOJET ULTRA AVX THROMBECTOMY SETFebruary 14, 2014
K091593ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETSJune 22, 2009
K090253ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL 106552-001, ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODApril 8, 2009
K082382ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039December 12, 2008
K081989MODIFICATION TO FETCH ASPIRATION CATHETERSeptember 26, 2008
K081454GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICEJune 13, 2008
K080806ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY SET, MODEL 106608April 4, 2008
K073441ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039January 24, 2008
K072769ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553) THROMBECTOMY SETSNovember 14, 2007
K072269ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL: 106552September 8, 2007
K071336ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307August 24, 2007
K071514ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307July 31, 2007
K071342ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040, 105042, 106552, 105043, 105041, 106553, 1050July 31, 2007
K070363FETCH ASPIRATION CATHETERMay 11, 2007
K061951ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL XPEEDIOR 120November 22, 2006
K062172FETCH ASPIRATION CATHETERSeptember 20, 2006
K062220MODIFICATION TO GUARDDOG OCCLUSION SYSTEMAugust 11, 2006
K052256ANGIOJET XPEEDIOR 120 CATHETERNovember 10, 2005
K050794ANGIOJET DVX RHEOLYTIC THROMBECTOMY CATHETERApril 28, 2005
K042874ANGIOJET XMI CATHETER - RAPID EXCHANGE (XMI-RX)November 5, 2004