510(k) K082143— MICRO GUIDE CATHETER XP

Substantially Equivalent

Cordis Corp.

Clearance details

Applicant: Cordis Corp.
Product code: Code PDU
Advisory panel: Cardiovascular
Date received: 2008-07-30
Decision date: 2008-08-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Warren, NJ, US

Adverse events under product code PDU

product code PDU

Malfunction: 793
Total: 793

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.