Angioscore, Inc.
Medical device manufacturer in Fremont, CA.
13510(k) clearances
0PMA approvals
7recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K142983 | AngioSculpt PTA Scoring Balloon Catheter with HydroCross CoatingPNO · Special | 03/04/2015SE |
| K133998 | Angiosculpt Pta Scoring Balloon with Hydrocross CaotingPNO · Traditional | 04/18/2014SE |
| K122685 | Angiosculpt Pta Scoring Balloon CatheterPNO · Traditional | 01/11/2013SE |
| K112182 | Angiosculpt Pta Scoring Balloon CatheterPNO · Special | 08/26/2011SE |
| K110767 | Angiosculpt Pta Scoring Balloon CatheterPNO · Special | 04/15/2011SE |
| K101735 | Angiosculpt Pta Scoring Balloon Catheter Model 2039-XXYY, 2155-XXYYPNO · Special | 07/14/2010SE |
| K100303 | Angiosculpt Pta Scoring Balloon Catheter Model 2039-XXYY, 2076-XXYY, 2092-XXYY, 2105-XXYYPNO · Traditional | 03/22/2010SE |
| K091966 | Angiosculpt Pta Scoring Balloon Catheter, Models 2076-6040, 2092-6040, 2105-6040PNO · Special | 07/30/2009SE |
| K082059 | Angiosculpt Pta Scoring Balloon CatheterPNO · Special | 08/11/2008SE |
| K081220 | Modification to Angiosculpt Pta Scoring Balloon CatheterPNO · Special | 05/28/2008SE |
| K080151 | Angiosculpt Pta Scoring Balloon Catheter, Models 2076 and 2039PNO · Traditional | 04/25/2008SE |
| K072225 | Angiosculpt Pta Scoring Balloon CatheterPNO · Special | 10/12/2007SE |
| K050629 | Angiosculpt Scoring Balloon CatheterPNO · Traditional | 09/02/2005SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0842-2011 | AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 50 cm…Reports of distal bond failure which has resulted in peeling of the bond and/or detachment of the distal end… | 11/16/2010Terminated |
| Z-0841-2011 | AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 90 cm…Reports of distal bond failure which has resulted in peeling of the bond and/or detachment of the distal end… | 11/16/2010Terminated |
| Z-0840-2011 | AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 137 cm…Reports of distal bond failure which has resulted in peeling of the bond and/or detachment of the distal end… | 11/16/2010Terminated |
| Z-0839-2011 | AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 137 cm…Reports of distal bond failure which has resulted in peeling of the bond and/or detachment of the distal end… | 11/16/2010Terminated |
| Z-0838-2011 | AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 137 cm…Reports of distal bond failure which has resulted in peeling of the bond and/or detachment of the distal end… | 11/16/2010Terminated |
| Z-2218-2010 | AngioSculpt Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter…Separations of the PTCA catheter shaft at the guide wire exit port have occurred during treatment of… | 12/04/2009Terminated |
| Z-0591-2008 | AngioSculpt PTCA Scoring Balloon Catheter, Catalog (REF) Number: 2027-2510, size 2.5mm x…Mis-labeling: Product labeling on product pouch indicates wrong size, the correct size is on the product… | 11/13/2007Terminated |