PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPS— 510(k) K003925

Substantially Equivalent

Cordis Neurovascular, Inc.

FDA 510(k) clearance K003925 for PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPS, Substantially Equivalent on 2001-01-08. Applicant: Cordis Neurovascular, Inc..

Clearance details

Applicant: Cordis Neurovascular, Inc.
Product code: Code KRA
Advisory panel: Cardiovascular
Date received: 2000-12-20
Decision date: 2001-01-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Miami Lake, FL, 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.