SELECTIVE INFUSION II CATHETER— 510(k) K914751

Substantially Equivalent

Advanced Cardiovascular Systems, Inc.

FDA 510(k) clearance K914751 for SELECTIVE INFUSION II CATHETER, Substantially Equivalent on 1993-05-24. Applicant: Advanced Cardiovascular Systems, Inc..

Clearance details

Applicant: Advanced Cardiovascular Systems, Inc.
Product code: Code KRA
Advisory panel: Cardiovascular
Date received: 1991-10-22
Decision date: 1993-05-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KRA

product code KRA

Death: 234
Injury: 1,029
Malfunction: 3,012
Other: 2
Total: 4,277

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.