CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set— 510(k) K193380

Substantially Equivalent

Codman & Shurtleff, Inc.

FDA 510(k) clearance K193380 for CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set, Substantially Equivalent on 2020-07-20. Applicant: Codman & Shurtleff, Inc..

Clearance details

Applicant: Codman & Shurtleff, Inc.
Product code: Code NRY
Advisory panel: Cardiovascular
Date received: 2019-12-05
Decision date: 2020-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raynham, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NRY

product code NRY

Death: 411
Injury: 1,712
Malfunction: 1,855
Total: 3,978

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.