PERCUTANEOUS ANGIOGRAPHIC NEEDLES— 510(k) K845037

Name: FDA 510(k) clearance K845037
Creator: U.S. Food and Drug Administration
Published: 1985-06-21

Substantially Equivalent

Mallinckrodt Critical Care

FDA 510(k) clearance K845037 for PERCUTANEOUS ANGIOGRAPHIC NEEDLES, Substantially Equivalent on 1985-06-21. Applicant: Mallinckrodt Critical Care. Device class: 2.

Clearance details

Applicant: Mallinckrodt Critical Care
Product code: Code DYB
Device class: Class 2
Regulation: 21 CFR 870.1340
Advisory panel: Cardiovascular
Date received: 1984-12-27
Decision date: 1985-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St Louis, MO, US

Download summary PDF View on FDA.gov ↗

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K874568 — HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITOR1988-01-06
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Adverse events under product code DYB

product code DYB

Death: 808
Injury: 5,922
Malfunction: 16,516
Other: 5
Total: 23,251

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.