K140438

Substantially Equivalent

MICRO GUIDE CATHETER ELITE

Applicant: Cordis Corp., A Johnson & Johnson Co.
Product code: PDU
Advisory panel: Cardiovascular
Date received: 2014-02-21
Decision date: 2014-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, 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.