510(k) K091966— ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076-6040, 2092-6040, 2105-6040

Substantially Equivalent

Angioscore, Inc.

Clearance details

Applicant: Angioscore, Inc.
Product code: Code PNO
Advisory panel: Cardiovascular
Date received: 2009-07-01
Decision date: 2009-07-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Fremont, CA, US

Adverse events under product code PNO

product code PNO

Malfunction: 1,646
Total: 1,646

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.