S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0— 510(k) K002116

Name: FDA 510(k) clearance K002116
Creator: U.S. Food and Drug Administration
Published: 2000-08-09

Substantially Equivalent

Medical Device Consultants, Inc.

FDA 510(k) clearance K002116 for S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0, Substantially Equivalent on 2000-08-09. Applicant: Medical Device Consultants, Inc.. Device class: 2.

Clearance details

Applicant: Medical Device Consultants, Inc.
Product code: Code DTQ
Device class: Class 2
Regulation: 21 CFR 870.4220
Advisory panel: Cardiovascular
Date received: 2000-07-13
Decision date: 2000-08-09
Decision: Substantially Equivalent
Clearance type: Special
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DTQ

product code DTQ

Death: 123
Malfunction: 4,822
Other: 1
Total: 4,946

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.