ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2076-XXYY, 2092-XXYY, 2105-XXYY— 510(k) K100303
Substantially EquivalentAngioscore, Inc.
FDA 510(k) clearance K100303 for ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2076-XXYY, 2092-XXYY, 2105-XXYY, Substantially Equivalent on 2010-03-22. 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
Recent devices under product code PNO
view all- K260012 — UltraScore Focused Force PTA Balloon
- K243944 — Aperta NSE PTA Balloon Dilatation Catheter
- K242254 — D·Kutting LL Peripheral Scoring Balloon Dilatation Catheter
- K241478 — Tri-Wedge PTA Scoring Balloon Dilatation Catheter
- K232258 — XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter
More clearances from Angioscore, Inc.
view allAdverse 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.