ANTEGRADE/RETROGRADE Y W/INTEGRAL SELECTOR SWIT.— 510(k) K900994

Substantially Equivalent

Dlp, Inc.

FDA 510(k) clearance K900994 for ANTEGRADE/RETROGRADE Y W/INTEGRAL SELECTOR SWIT., Substantially Equivalent on 1990-08-15. Applicant: Dlp, Inc..

Clearance details

Applicant: Dlp, Inc.
Product code: Code DTL
Advisory panel: Cardiovascular
Date received: 1990-03-02
Decision date: 1990-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grand Rapids, MI, US

Download summary PDF View on FDA.gov ↗

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.