Medical Device Manufacturer · US , Santa Clara , CA

Guidant Corp. - FDA 510(k) Cleared Devices

71 submissions · 56 cleared · Since 1997

71

Total

56

Cleared

0

Denied

FDA 510(k) Regulatory Record - Guidant Corp. Cardiovascular ✕

50 devices

1-12 of 50

Cleared Jun 22, 2006

HI-TORQUE WHISPER VIEW GUIDE WIRE

Cardiovascular · 28d

Cleared Nov 12, 2004

RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM

Cardiovascular · 22d

Cleared Aug 31, 2004

ACCUNET EMBOLIC PROTECTION SYSTEM, RX ACCUNET EMBOLIC PROTECTION SYSTEM

Cardiovascular · 26d

Cleared Aug 26, 2003

HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING

Cardiovascular · 88d

Cleared Jul 23, 2003

RAPIDO CUT-AWAY CUTTER

Cardiovascular · 76d

Cleared May 20, 2003

IS-1 HEMOSTASIS VALVE, MODEL 6799

Cardiovascular · 15d

Cleared Jan 24, 2003

MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE

Cardiovascular · 21d

Cleared Dec 10, 2002

AGILTRAC .035 PERIPHERAL DILATATION CATHETER

Cardiovascular · 67d

Cleared Oct 28, 2002

HI-TORQUE WHISPER LS

Cardiovascular · 25d

Cleared Sep 13, 2002

AGILTRAC .035 PERIPHERAL DILATATION CATHETER

Cardiovascular · 25d

Cleared Sep 13, 2002

GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500

Cardiovascular · 14d

Cleared Aug 02, 2002

RAPIDO GUIDING CATHETER, 6F MODEL# 6776

Cardiovascular · 88d

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