K131914

Substantially Equivalent

OFFROAD RE-ENTRY CATHETER SYSTEM

Applicant: Boston Scientific Corp
Product code: PDU
Advisory panel: Cardiovascular
Date received: 2013-06-26
Decision date: 2013-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maple Grove, MN, 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.