Product code MAF ยท Class 3
Stent, Coronary
0510(k)s in 12 months (0 all time)
0recalls in 12 months (22 all time)
1recalls that name a 510(k)
Top companies in MAF
| Company | 510(k)s | Recalls |
|---|---|---|
| Abbott Vascular-Cardiac Therapies dba Guidant Corporation | 0 | 6 |
| Boston Scientific Scimed | 0 | 5 |
| Boston Scientific Corporation | 0 | 3 |
| Cordis Corporation | 0 | 3 |
| Abbott Vascular Devices | 0 | 1 |
| Edwards Lifesciences Llc | 0 | 1 |
| Guidant Corporation ACS | 0 | 1 |
| Guidant Corporation Advanced CardiovascularSystem | 0 | 1 |
| Numed Inc | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 24, 2019 | Boston Scientific Corporation Rebel Monorail PtCr Coronary Stent System, REF / Catalog No. H7493927324300, Rebel MR OUS 3.0mm x 24mm. The Rebel Monorail (MR) Stent System is a balloon expandable Platinum Chromium (PtCr) Alloy st Terminated |
MAF | None listed |
| Feb 16, 2017 | Cordis Corporation Cordis S.M.A.R.T. Flex Vascular Stent System Terminated |
MAF | None listed |
| Oct 21, 2009 | Boston Scientific Corporation Boston Scientific Liberte Monorail and Over-the-Wire Coronary Stent Systems to be relabeled as VeriFLEX".
The Liberte Coronary Stent System consists of a balloon expandable stainless steel stent, p Terminated |
MAF | 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 |
| 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 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 |
| May 18, 2005 | Edwards Lifesciences Llc Edwards LifeStent NT Self-Expanding Stent and Delivery System;
Models: NT186901(D); NT187901(D); NT186902(D); NT187902(D); NT356901(D); NT357901(D);NT356902; NT357902(D) Terminated |
MAF | None listed |
| Apr 13, 2005 | Guidant Corporation Advanced CardiovascularSystem Voyager RX Coronary Dilatation Catheter Terminated |
MAF | None listed |
| Jul 27, 2004 | Boston Scientific Corporation Express 2 Monorail Coronary Stent Systems (bare metal stents) - balloon expandable Express 316L stainless steel Stent premounted on a MONORAIL catheter with a Dynaleap balloon. Terminated |
MAF | None listed |
| Jul 20, 2004 | Cordis Corporation This device is labeled as Sterile and is packaged in a Tyvek pouch with the following labeling: PALMAZ Genesis TRANSHEPATIC BILIARY STENT on Aviator RX Delivery System REF Cat. No. Cordis ENDOVASCULA Terminated |
MAF | K010411 |
| Jul 20, 2004 | Cordis Corporation The device is in a tyvek pouch and is labeled in part: Aviator Peripheral Dilatation Catheter REF Cat. No. Lot No., Use By Manufactured for: Cordis Europa N.V. 9301 LJRoden The Netherlands Method of Terminated |
MAF | None listed |
| Aug 20, 2003 | Abbott Vascular Devices BiodivYsio SV Over The Wire (OTW) Coronary Stent, 2.25 mm diameter;
Catalog #: B3225-10, Lot #: 010586G;
Catalog #: B3225-10, Lot #: 030176G;
Catalog #: B3225-15, Lot #: 010626G;
Catalog #: B3225-18 Terminated |
MAF | None listed |
| Aug 12, 2003 | Boston Scientific Scimed Boston Scientific Scimed Monorail Express 2 Coronary Stent System, 3.5 mm x 32 mm, Catalog number 35050-3235 Terminated |
MAF | None listed |
| Jul 8, 2003 | Numed Inc CP STENT (Cheatham Platinum), a prescription device, composed of 90% platinum/10% iridium wire arranged in laser welded rows with a ''zig'' pattern. The number of zigs can be varied and will impact t Terminated |
MAF | None listed |
| May 22, 2003 | Guidant Corporation ACS MULTI-LINK Pixel Coronary Stent System
Size: 2.0 x 13 mm OTW
Part Number: 1007830-13 Terminated |
MAF | None listed |
| Apr 22, 2003 | Boston Scientific Scimed Boston Scientific Scimed Radius 4.0 mm x 31 mm Self-Expanding Coronary Stent with Over-the-Wire Delivery System, Catalog Number H74917500401 Terminated |
MAF | None listed |
| Apr 22, 2003 | Boston Scientific Scimed Boston Scientific Scimed Radius 3.0 mm x 31 mm Self-Expanding Coronary Stent with Over-the-Wire Delivery System, Catalog Number H74917500301 Terminated |
MAF | None listed |
| Apr 22, 2003 | Boston Scientific Scimed Boston Scientific Scimed Radius Monorail 4.0 mm x 31 mm Stent Systems, Catalog Number H74917485400 Terminated |
MAF | None listed |
| Apr 9, 2003 | Boston Scientific Scimed Boston Scientific Scimed Express 2 Monorail 2.5 mm 12mm Coronary Stent System, Catalog Number H7493505012250 Terminated |
MAF | None listed |
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