Medtronic Vascular - FDA 510(k) Cleared Devices
Recent clearances: Steerant™ Super Stiff Guidewire, 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter, 5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter
475
Total
453
Cleared
0
Denied
FDA 510(k) Regulatory Record - Medtronic Vascular General & Plastic Surgery ✕
10 devices
Cleared
Apr 24, 2007
CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE, MODELS 49260 AND 49261
General & Plastic Surgery
82d
Cleared
Oct 11, 2006
CARDIOBLATE NAVIGATOR TISSUE DISSECTION DEVICE
General & Plastic Surgery
28d
Cleared
Aug 02, 2006
U-CLIP DEVICE, MODEL NC65
General & Plastic Surgery
13d
Cleared
Dec 16, 2005
U-CLIP DEVICE, MODELS B140, B160 AND B180
General & Plastic Surgery
25d
Cleared
Dec 21, 2004
CARDIOBLATE DISPERSIVE ELECTRODE ADAPTER (ACCESSORY), MODEL 60884
General & Plastic Surgery
22d
Cleared
Jul 17, 2003
CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM
General & Plastic Surgery
90d
Cleared
Aug 28, 2002
PRECISION PLUS TUNA OFFICE SYSTEM
General & Plastic Surgery
86d
Cleared
May 28, 1992
PROMEON HYDROGEL DRESSING #45 STERILE W/O MESH
General & Plastic Surgery
183d
Cleared
May 28, 1992
PROMEON HYDROGEL DRESSING #45 STERILE W/ MESH
General & Plastic Surgery
183d
Cleared
Apr 28, 1992
PROMEON HYDROGEL DRESSING #45 NONSTERILE W/ MESH
General & Plastic Surgery
153d