AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm)— 510(k) K183464

Substantially Equivalent

Stryker

FDA 510(k) clearance K183464 for AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm), Substantially Equivalent on 2019-03-13. Applicant: Stryker.

Clearance details

Applicant: Stryker
Product code: Code NRY
Advisory panel: Cardiovascular
Date received: 2018-12-14
Decision date: 2019-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, 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.