Medical Device Manufacturer · US , St. Paul , MN

Guidant Corporation - FDA 510(k) Cleared Devices

15 submissions · 12 cleared · Since 2003

15

Total

12

Cleared

0

Denied

FDA 510(k) Regulatory Record - Guidant Corporation Cardiovascular ✕

10 devices

1-10 of 10

Cleared May 30, 2006

HI-TORQUE ADVANCE AND ADVANCE LITE GUIDE WIRE

Cardiovascular · 98d

Cleared Mar 03, 2006

ACUITY STEERABLE STYLET ACCESSORY

Cardiovascular · 128d

Cleared Feb 13, 2006

EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832.

Cardiovascular · 115d

Cleared Aug 18, 2005

MODIFICATION TO: RX ACCUNET EMBOLIC PROTECTION SYSTEM

Cardiovascular · 9d

Cleared Aug 16, 2005

RX ACCUNET EMBOLIC PROTECTION SYSTEM

Cardiovascular · 7d

Cleared Aug 06, 2004

FINISHING WIRE SUPPORTRAK

Cardiovascular · 37d

Cleared Jul 12, 2004

CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020

Cardiovascular · 28d

Cleared Mar 03, 2004

RAPIDO CUT-AWAY BLEEDBACK CONTROL VALVE (BBCV), MODEL 7568

Cardiovascular · 257d

Cleared Jul 02, 2003

RAPIDO CUT-A-WAY ROTATING HEMOSTASIS VALVE

Cardiovascular · 30d

Cleared Jun 25, 2003

RAPIDO CUT-AWAY GUIDING CATHETER

Cardiovascular · 42d