LARGE LUMEN Y ADAPTER W/ROTATING DEVICE— 510(k) K880831

Substantially Equivalent

Interventional Medical, Inc.

FDA 510(k) clearance K880831 for LARGE LUMEN Y ADAPTER W/ROTATING DEVICE, Substantially Equivalent on 1988-05-10. Applicant: Interventional Medical, Inc..

Clearance details

Applicant: Interventional Medical, Inc.
Product code: Code DTL
Advisory panel: Cardiovascular
Date received: 1988-03-01
Decision date: 1988-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danvers, MA, US

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Adverse events under product code DTL

product code DTL

Malfunction: 770
Total: 770

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.