TRANSIT-2 INFUSION CATHETER— 510(k) K950910

Substantially Equivalent

Cordis Neurovascular, Inc.

FDA 510(k) clearance K950910 for TRANSIT-2 INFUSION CATHETER, Substantially Equivalent on 1995-08-08. Applicant: Cordis Neurovascular, Inc..

Clearance details

Applicant: Cordis Neurovascular, Inc.
Product code: Code DQO
Advisory panel: Cardiovascular
Date received: 1995-02-13
Decision date: 1995-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami Lakes, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQO

product code DQO

Death: 35
Injury: 993
Malfunction: 1,772
Other: 5
Total: 2,805

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.