FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANGIOSCULPT PTA SCORING BALLOON CATHETER
K Number: K082059
·
Decision Aug 11, 2008
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
44
Applicant Total
13
Review Days
21
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Basic Information
- Device Name
- ANGIOSCULPT PTA SCORING BALLOON CATHETER
- K Number
- K082059
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Angioscore, Inc.
- Date Received
- July 21, 2008
- Decision Date
- August 11, 2008
- Product Code
- PNO
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PNO | Catheter, Percutaneous, Cutting/Scoring | FDA class 2 | Cardiovascular |
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FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Angioscore, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K142983 | AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating | Mar 4, 2015 | Substantially Equivalent |
| K133998 | ANGIOSCULPT PTA SCORING BALLOON WITH HYDROCROSS CAOTING | Apr 18, 2014 | Substantially Equivalent |
| K122685 | ANGIOSCULPT PTA SCORING BALLOON CATHETER | Jan 11, 2013 | Substantially Equivalent |
| K112182 | ANGIOSCULPT PTA SCORING BALLOON CATHETER | Aug 26, 2011 | Substantially Equivalent |
| K110767 | ANGIOSCULPT PTA SCORING BALLOON CATHETER | Apr 15, 2011 | Substantially Equivalent |
| K101735 | ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2155-XXYY | Jul 14, 2010 | Substantially Equivalent |
| K100303 | ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2076-XXYY, 2092-XXYY, 2105-XXYY | Mar 22, 2010 | Substantially Equivalent |
| K091966 | ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076-6040, 2092-6040, 2105-6040 | Jul 30, 2009 | Substantially Equivalent |
| K081220 | MODIFICATION TO ANGIOSCULPT PTA SCORING BALLOON CATHETER | May 28, 2008 | Substantially Equivalent |
| K080151 | ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076 AND 2039 | Apr 25, 2008 | Substantially Equivalent |