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Abbott Vascular-Cardiac Therapies dba Guidant Corporation

17 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Peripheral Dilatation Catheter, Viatrac 14 Plus 5.0mm x 15mm x 80cm, Part Number 1008194-1 recall (Z-1178-2010)Abbott Vascular-Cardiac Therapies dba Guidant Corporation2010-03-22
Xact 9 mm x 20 mm x 136 cm (Part Number 82089-01) The Xact Carotid Stent System, used in c recall (Z-1152-2010)Abbott Vascular-Cardiac Therapies dba Guidant Corporation2010-03-16
Xact 10 mm x 20 mm x 136 cm (Part Number 82099-01) The Xact Carotid Stent System, used in recall (Z-1153-2010)Abbott Vascular-Cardiac Therapies dba Guidant Corporation2010-03-16
RX ACCULINK Carotid Stent System, 10x40 mm, Product Number: 1011344-40, Lot Number: 908185 recall (Z-0749-2010)Abbott Vascular-Cardiac Therapies dba Guidant Corporation2010-01-29
POWERSAIL Coronary Dilatation Catheter: 3.25x18mm (US) Part #1005524-18 recall (Z-1804-2009)Abbott Vascular-Cardiac Therapies dba Guidant Corporation2009-07-29
POWERSAIL Coronary Dilatation Catheter: 4.0x8mm (CE) Part #1005726-08 recall (Z-1805-2009)Abbott Vascular-Cardiac Therapies dba Guidant Corporation2009-07-29
POWERSAIL Coronary Dilatation Catheter: 2.75x18mm (US) Part #1005522-18 recall (Z-1806-2009)Abbott Vascular-Cardiac Therapies dba Guidant Corporation2009-07-29
POWERSAIL Coronary Dilatation Catheter: 3.25x8mm (US) Part #1005524-08 recall (Z-1807-2009)Abbott Vascular-Cardiac Therapies dba Guidant Corporation2009-07-29
Abbott Vascular, StarClose Vascular Closure System Part Number 14677-01, for closure of fe recall (Z-1657-2009)Abbott Vascular-Cardiac Therapies dba Guidant Corporation2009-07-06
VOYAGER NC Coronary Dilatation Catheter, 4.5 X 8.0 mm. The device is used for in the follo recall (Z-0938-2009)Abbott Vascular-Cardiac Therapies dba Guidant Corporation2009-02-03
VOYAGER NC Coronary Dilatation Catheter, 4.5 X 12.0 mm. The device is used for in the foll recall (Z-0939-2009)Abbott Vascular-Cardiac Therapies dba Guidant Corporation2009-02-03
6F Viking Guiding Catheter, Percutaneous catheter, Shape ALR 1.2, Part Number: 1001934-06, recall (Z-1633-2008)Abbott Vascular-Cardiac Therapies dba Guidant Corporation2008-08-13
6F Viking Guiding Catheter, Percutaneous catheter Shape BP-L, Part Number: 1001970-06, Abb recall (Z-1634-2008)Abbott Vascular-Cardiac Therapies dba Guidant Corporation2008-08-13
Multi-Link Vision RX Coronary Stent System, 3.0 x 15mm, Part number 1007848-15, lot number recall (Z-1211-2007)Abbott Vascular-Cardiac Therapies dba Guidant Corporation2007-08-29
ACS Rotating Hemostatic Valve, 0.096 inch, for use with a dilatation catheter - Reference recall (Z-0390-2007)Abbott Vascular-Cardiac Therapies dba Guidant Corporation2007-02-01
ACS DUOSTAT Rotating Hemostatic Valve, 0.096 inch, for use with a dilatation catheter - Re recall (Z-0391-2007)Abbott Vascular-Cardiac Therapies dba Guidant Corporation2007-02-01
ACS Rotating Hemostatic Valve, .115 inch, for use with a dilatation catheter - Reference N recall (Z-0392-2007)Abbott Vascular-Cardiac Therapies dba Guidant Corporation2007-02-01

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Every clearance here is in the API, with alerts when new ones post.