MICROVASIVE INSURG GEENEN CBD GUIDE WIRE— 510(k) K931650

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K931650 for MICROVASIVE INSURG GEENEN CBD GUIDE WIRE, Substantially Equivalent on 1993-06-25. Applicant: Boston Scientific Corp.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code OCY
Advisory panel: Gastroenterology, Urology
Date received: 1993-04-05
Decision date: 1993-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OCY

product code OCY

Injury: 186
Malfunction: 578
Total: 764

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.