Company
Abbott Vascular-Cardiac Therapies dba Guidant Corporation
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
17recalls (0 in 12 months)
6recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 22, 2010 | Abbott Vascular-Cardiac Therapies dba Guidant Corporation Peripheral Dilatation Catheter, Viatrac 14 Plus 5.0mm x 15mm x 80cm, Part Number 1008194-15. Manufactured by Abbott Vascular, Temecula, CA.
Indicated to dilate stenosis in the peripheral vasculature Terminated |
LIT | K072798 |
| Mar 16, 2010 | Abbott Vascular-Cardiac Therapies dba Guidant Corporation Xact 10 mm x 20 mm x 136 cm (Part Number 82099-01)
The Xact Carotid Stent System, used in conjunction with Emboshield Embolic Protection System is indicated for the improvement of the lumen diameter Terminated |
NIM | None listed |
| Mar 16, 2010 | Abbott Vascular-Cardiac Therapies dba Guidant Corporation Xact 9 mm x 20 mm x 136 cm (Part Number 82089-01)
The Xact Carotid Stent System, used in conjunction with Emboshield Embolic Protection System is indicated for the improvement of the lumen diameter o Terminated |
NIM | None listed |
| Jan 29, 2010 | Abbott Vascular-Cardiac Therapies dba Guidant Corporation RX ACCULINK Carotid Stent System, 10x40 mm, Product Number: 1011344-40, Lot Number: 9081851.
Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who re Terminated |
NIM | None listed |
| Jul 29, 2009 | Abbott Vascular-Cardiac Therapies dba Guidant Corporation POWERSAIL Coronary Dilatation Catheter: 3.25x8mm (US)
Part #1005524-08 Terminated |
MAF | None listed |
| Jul 29, 2009 | Abbott Vascular-Cardiac Therapies dba Guidant Corporation POWERSAIL Coronary Dilatation Catheter: 2.75x18mm (US)
Part #1005522-18 Terminated |
MAF | None listed |
| Jul 29, 2009 | Abbott Vascular-Cardiac Therapies dba Guidant Corporation POWERSAIL Coronary Dilatation Catheter: 4.0x8mm (CE)
Part #1005726-08 Terminated |
MAF | None listed |
| Jul 29, 2009 | Abbott Vascular-Cardiac Therapies dba Guidant Corporation POWERSAIL Coronary Dilatation Catheter: 3.25x18mm (US)
Part #1005524-18 Terminated |
MAF | None listed |
| Jul 6, 2009 | Abbott Vascular-Cardiac Therapies dba Guidant Corporation Abbott Vascular, StarClose Vascular Closure System Part Number 14677-01, for closure of femoral artery access sites after cardiovascular catheterization. Terminated |
MGB | None listed |
| Feb 3, 2009 | Abbott Vascular-Cardiac Therapies dba Guidant Corporation VOYAGER NC Coronary Dilatation Catheter, 4.5 X 12.0 mm.
The device is used for in the following: (1) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the Terminated |
LOX | None listed |
| Feb 3, 2009 | Abbott Vascular-Cardiac Therapies dba Guidant Corporation VOYAGER NC Coronary Dilatation Catheter, 4.5 X 8.0 mm.
The device is used for in the following: (1) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the p Terminated |
MAF | None listed |
| Aug 13, 2008 | Abbott Vascular-Cardiac Therapies dba Guidant Corporation 6F Viking Guiding Catheter, Percutaneous catheter Shape BP-L, Part Number: 1001970-06, Abbott Vascular, Santa Clara, CA 95054.
Intended to provide a pathway through which therapeutic and diagnostic d Terminated |
DQY | K972484 |
| Aug 13, 2008 | Abbott Vascular-Cardiac Therapies dba Guidant Corporation 6F Viking Guiding Catheter, Percutaneous catheter, Shape ALR 1.2, Part Number: 1001934-06, Abbott Vascular, Santa Clara, CA 95054.
Designed to provide a pathway trough which therapeutic and diagnosti Terminated |
DQY | K972484 |
| Aug 29, 2007 | Abbott Vascular-Cardiac Therapies dba Guidant Corporation Multi-Link Vision RX Coronary Stent System, 3.0 x 15mm, Part number 1007848-15, lot number 7052951 Terminated |
MAF | None listed |
| Feb 1, 2007 | Abbott Vascular-Cardiac Therapies dba Guidant Corporation ACS Rotating Hemostatic Valve, .115 inch, for use with a dilatation catheter - Reference Number 23245 Terminated |
DTL | K934624 |
| Feb 1, 2007 | Abbott Vascular-Cardiac Therapies dba Guidant Corporation ACS DUOSTAT Rotating Hemostatic Valve, 0.096 inch, for use with a dilatation catheter - Reference Number 23244 Terminated |
DTL | K854261 K861847 |
| Feb 1, 2007 | Abbott Vascular-Cardiac Therapies dba Guidant Corporation ACS Rotating Hemostatic Valve, 0.096 inch, for use with a dilatation catheter - Reference Number 23242 Terminated |
DTL | K854261 K861847 |