Stent, Coronary
FDA product code MAF · Class III (high risk) · Cardiovascular
The formerly known device, Cardiovascular Stent, coded as "MAF" has been modified and is currently known and classified as a "Coronary Stent". This device is a metal scaffold placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen.
0510(k) clearances
21PMA approvals
9recalls
Implantimplanted device
PMA approvals
- P130030 Rebel Platinum Chromium Coronary Stent System Monorail and Over the Wire · Boston Scientific Corp · 03/10/2026
- P160014 COBRA PzF NanoCoated Coronary Stent System · Celonova Biosciences, Inc. · 02/21/2017
- P150039 Tryton Side Branch Stent · Poseidon Medical, Inc. · 02/21/2017
- P160003 PRO-KINETIC ENERGY COBALT CHROMIUM (CoCr) CORONARY STENT SYSTEM · Biotronik AG · 02/14/2017
- P110004 Presillion Plus Cocr Coronary Stent RX System · Medinol, Ltd. · 04/12/2012
- P030037 Rithron-Xr Coronary Stent System · Biotronik GmbH & Co. KG · 04/29/2005
- P040016 Veriflex (Liberte) Bare-Metal Coronary Stent System · Boston Scientific Scimed, Inc. · 04/12/2005
- P020040 Nirflex Premounted Stent · Medinol, Ltd. · 10/24/2003
- P030009 Driver Over-The-Wire, Rapid Exchange, and Multi-Exchange Coronary Stent Systems · Medtronic, Ireland · 10/01/2003
- P020047 Multi-Link VISION/MINI/8 Coronary Stent Systems · Abbott Vascular · 07/16/2003
- P020009 Express/Express 2 MR & Otw Coronary Stent Systems · Boston Scientific Scimed, Inc. · 09/11/2002
- P000022 Bestent 2 Over-The-Wire (Otw)/Rapid Exchange Coronary Stent Delivery System · Medtronic Vascular · 10/16/2000
- P000011 Biodivysio AS PS (Phosphorylcholine)Coated Stent Delivery System · Abbott Vascular, Inc. · 09/29/2000
- P980009 Magic Wallstent Endoprothesis · Boston Scientific Scimed, Inc. · 09/29/1998
- P980001 Nir on TM Ranger TM Premounted Stent System · Boston Scientific Corp · 08/11/1998
- P970061 Scimed Radius Coronary Stent with Delivery System · Boston Scientific Scimed, Inc. · 07/16/1998
- P970035 Ave Micro Stent II Over-The-Wire Coronary Stent System and Ave GFX Over-The-Wire Coronary Stent System · Medtronic, Ireland · 12/23/1997
- P970020 Multi-Link Ultra/ Zeta Coronary Stent Systems · Abbott Vascular, Inc. · 10/02/1997
- P960010 Medtronic Wiktor Prime Coronary Stent Delivery System · Medtronics Interventional Vascular · 06/27/1997
- P900043 Palmaz-Schatz(Tm) Balloon Expandable Stent · Cordis Corp. · 08/02/1994
- P910030 Gianturco-Roubin Coronary Flex-Stent(Tm) · Cook, Inc. · 02/08/1993
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0580-2020 Class II | Rebel Monorail PtCr Coronary Stent System, REF / Catalog No. H7493927324300, Rebel MR…Certain dilation and extension catheters are being recalled because these catheters may have missed the… | Boston Scientific Corporation | 10/24/2019Terminated |
| Z-1826-2017 Class II | Cordis S.M.A.R.T. Flex Vascular Stent SystemDeployment Difficulty. | Cordis Corporation | 02/16/2017Terminated |
| Z-0068-2010 | Boston Scientific Liberte Monorail and Over-the-Wire Coronary Stent Systems to be…Boston Scientific initiated a field correction for the Liberte Bare-Metal coronary stent products. They have… | Boston Scientific Corporation | 09/11/2009Terminated |
| Z-1807-2009 | POWERSAIL Coronary Dilatation Catheter: 3.25x8mm (US) Part #1005524-08Distal shaft of the POWERSAIL coronary Dilatation Catheters exhibits damage that may result in a leak of… | Abbott Vascular-Cardiac Therapies dba… | 06/17/2009Terminated |
| Z-1806-2009 | POWERSAIL Coronary Dilatation Catheter: 2.75x18mm (US) Part #1005522-18Distal shaft of the POWERSAIL coronary Dilatation Catheters exhibits damage that may result in a leak of… | Abbott Vascular-Cardiac Therapies dba… | 06/17/2009Terminated |
| Z-1805-2009 | POWERSAIL Coronary Dilatation Catheter: 4.0x8mm (CE) Part #1005726-08Distal shaft of the POWERSAIL coronary Dilatation Catheters exhibits damage that may result in a leak of… | Abbott Vascular-Cardiac Therapies dba… | 06/17/2009Terminated |
| Z-1804-2009 | POWERSAIL Coronary Dilatation Catheter: 3.25x18mm (US) Part #1005524-18Distal shaft of the POWERSAIL coronary Dilatation Catheters exhibits damage that may result in a leak of… | Abbott Vascular-Cardiac Therapies dba… | 06/17/2009Terminated |
| Z-0938-2009 | VOYAGER NC Coronary Dilatation Catheter, 4.5 X 8.0 mm. The device is used for in the…The recall was initiated after Abbott Vascular received reports the protective, yellow balloon sheath of the… | Abbott Vascular-Cardiac Therapies dba… | 11/05/2008Terminated |
| Z-1211-2007 | Multi-Link Vision RX Coronary Stent System, 3.0 x 15mm, Part number 1007848-15, lot…The affected single lot did not meet an internal specification. One unit failed the test criteria for stent… | Abbott Vascular-Cardiac Therapies dba… | 07/16/2007Terminated |