IMPACT TURBO CATH— 510(k) K851611

Substantially Equivalent

Impact Instrumentation, Inc.

FDA 510(k) clearance K851611 for IMPACT TURBO CATH, Substantially Equivalent on 1985-06-05. Applicant: Impact Instrumentation, Inc..

Clearance details

Applicant: Impact Instrumentation, Inc.
Product code: Code JOL
Advisory panel: General Hospital
Date received: 1985-04-09
Decision date: 1985-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bogota, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JOL

product code JOL

Death: 7
Injury: 177
Malfunction: 1,306
Other: 1
Total: 1,491

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.