Company ยท US
Angioscore, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2015. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
7recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 4, 2015 | K142983 | AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating Angioscore, Inc. | PNO |
| Apr 18, 2014 | K133998 | ANGIOSCULPT PTA SCORING BALLOON WITH HYDROCROSS CAOTING Angioscore, Inc. | PNO |
| Jan 11, 2013 | K122685 | ANGIOSCULPT PTA SCORING BALLOON CATHETER Angioscore, Inc. | PNO |
| Aug 26, 2011 | K112182 | ANGIOSCULPT PTA SCORING BALLOON CATHETER Angioscore, Inc. | PNO |
| Apr 15, 2011 | K110767 | ANGIOSCULPT PTA SCORING BALLOON CATHETER Angioscore, Inc. | PNO |
| Jul 14, 2010 | K101735 | ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2155-XXYY Angioscore, Inc. | PNO |
| Mar 22, 2010 | K100303 | ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2076-XXYY, 2092-XXYY, 2105-XXYY Angioscore, Inc. | PNO |
| Jul 30, 2009 | K091966 | ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076-6040, 2092-6040, 2105-6040 Angioscore, Inc. | PNO |
| Aug 11, 2008 | K082059 | ANGIOSCULPT PTA SCORING BALLOON CATHETER Angioscore, Inc. | PNO |
| May 28, 2008 | K081220 | MODIFICATION TO ANGIOSCULPT PTA SCORING BALLOON CATHETER Angioscore, Inc. | PNO |
| Apr 25, 2008 | K080151 | ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076 AND 2039 Angioscore, Inc. | PNO |
| Oct 12, 2007 | K072225 | ANGIOSCULPT PTA SCORING BALLOON CATHETER Angioscore, Inc. | PNO |
| Sep 2, 2005 | K050629 | ANGIOSCULPT SCORING BALLOON CATHETER Angioscore, Inc. | PNO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2011 | AngioScore Inc. AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 50 cm, 6.0mm x 20 mm balloon size, Part (REF) number: 2105-6020 Terminated |
DQY | K072225 K080151 +1 |
| Jan 4, 2011 | AngioScore Inc. AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 90 cm, 6.0mm x 20 mm balloon size, Part (REF) number: 2092-6020. Terminated |
DQY | K072225 K080151 +1 |
| Jan 4, 2011 | AngioScore Inc. AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 137 cm, 6.0 mm x 20 mm balloon size, Part (REF) number: 2076-6020. Terminated |
DQY | K072225 K080151 +1 |
| Jan 4, 2011 | AngioScore Inc. AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 137 cm, 5.0 mm x 20 mm balloon size, Part (REF) number: 2076-5020. Terminated |
DQY | K072225 K080151 +1 |
| Jan 4, 2011 | AngioScore Inc. AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter;
OTW 0.018" Platform, 137 cm, 4.0 mm x 20 mm balloon size. Part (REF) number: 2076-4020 Terminated |
DQY | K072225 K080151 +1 |
| Aug 18, 2010 | AngioScore Inc. AngioSculpt Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter, cutting/scoring, Easy Exchange (EX) delivery system, Manufactured by AngioScore, Fremont, CA.
Catheter is for use in the tr Terminated |
NWX | None listed |
| Jan 23, 2008 | AngioScore Inc. AngioSculpt PTCA Scoring Balloon Catheter, Catalog (REF) Number: 2027-2510, size 2.5mm x 10 mm, AngioScore, Inc., Fremont, CA. Terminated |
NWX | None listed |