ClearanceBrief
Panels › Cardiovascular › Product code PDU · Class 2

Catheter For Crossing Total Occlusions

Regulation 870.1250

1510(k)s in 12 months (58 all time)
0recalls in 12 months (7 all time)
7recalls that name a 510(k)
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Top companies in PDU

Company510(k)sRecalls
Avinger, Inc.100
Ra Medical Systems,Inc35
Spectranetics Corp.70
Cordis Corp., A Johnson & Johnson Co.40
Flowcardia, Inc.30
Lumend, Inc.30
Baylis Medical Co., Inc.20
Baylis Medical Technologies, Inc.20
Boston Scientific Corp20
C.R. Bard, Inc.20
Decided510(k)Device and applicantCode
Sep 2, 2005K052296CLIRPATH TURBO EXCIMER LASER CATHETERS
Spectranetics Corp.
PDU
Aug 18, 2005K0434652.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-011
Spectranetics Corp.
PDU
Jun 8, 2005K050916SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [PERIPHERAL]
Intra Luminal Therapeutics, Inc.
PDU
Apr 27, 2004K040067CLIRPATH EXCIMER LASER CATHETER
Spectranetics Corp.
PDU
Jan 7, 2004K033535LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIES
Lumend, Inc.
PDU
Nov 21, 2003K031842SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
Intra Luminal Therapeutics, Inc.
PDU
Jun 18, 2003K031005LUMEND FRONTRUNNER GW CTO CATHETER
Lumend, Inc.
PDU
Jan 23, 2003K023114LUMEND FRONTRUNNER CTO CATHETER
Lumend, Inc.
PDU

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