11F GUIDING CATHETER— 510(k) K963663

Substantially Equivalent

Boston Scientific /International Technologies

FDA 510(k) clearance K963663 for 11F GUIDING CATHETER, Substantially Equivalent on 1997-01-13. Applicant: Boston Scientific /International Technologies.

Clearance details

Applicant: Boston Scientific /International Technologies
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 1996-09-13
Decision date: 1997-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

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.