ANGIOSCULPT PTA SCORING BALLOON CATHETER— 510(k) K122685
Substantially EquivalentAngioscore, Inc.
FDA 510(k) clearance K122685 for ANGIOSCULPT PTA SCORING BALLOON CATHETER, Substantially Equivalent on 2013-01-11. Applicant: Angioscore, Inc.. Device class: 2.
Clearance details
- Applicant
- Angioscore, Inc.
- Product code
- Code PNO
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fremont, CA, US
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More clearances from Angioscore, Inc.
view all- K142983 — AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating
- K133998 — ANGIOSCULPT PTA SCORING BALLOON WITH HYDROCROSS CAOTING
- K112182 — ANGIOSCULPT PTA SCORING BALLOON CATHETER
- K110767 — ANGIOSCULPT PTA SCORING BALLOON CATHETER
- K101735 — ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2155-XXYY
Adverse events under product code PNO
product code PNO- Malfunction
- 1,646
- Total
- 1,646
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.