CARDIOSEARCH RIGHT ATRIAL CATH-— 510(k) K833873

Name: FDA 510(k) clearance K833873
Creator: U.S. Food and Drug Administration
Published: 1984-06-11

Substantially Equivalent

Cardio Search, Inc.

FDA 510(k) clearance K833873 for CARDIOSEARCH RIGHT ATRIAL CATH-, Substantially Equivalent on 1984-06-11. Applicant: Cardio Search, Inc.. Device class: 2.

Clearance details

Applicant: Cardio Search, Inc.
Product code: Code DQY
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 1983-11-08
Decision date: 1984-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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K842133 — EYRTHROCATH DOUBLE-LUMEN CENTRAL VENOUS1985-02-19
K841880 — ERYTHROCATH UMBILICAL CATHETER1985-01-14
K832064 — VENOUS CATHETER1983-08-08

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.