CARDIAC CATHETERIZATION PACK— 510(k) K850337

Name: FDA 510(k) clearance K850337
Creator: U.S. Food and Drug Administration
Published: 1985-02-25

Substantially Equivalent

Marwood Medical, Inc.

FDA 510(k) clearance K850337 for CARDIAC CATHETERIZATION PACK, Substantially Equivalent on 1985-02-25. Applicant: Marwood Medical, Inc.. Device class: 2.

Clearance details

Applicant: Marwood Medical, Inc.
Product code: Code DRE
Device class: Class 2
Regulation: 21 CFR 870.1310
Advisory panel: Cardiovascular
Date received: 1985-01-28
Decision date: 1985-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Greensboro, NC, US

Download summary PDF View on FDA.gov ↗

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More clearances from Marwood Medical, Inc.

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K850340 — EYE PROCEDURE PACK1985-05-22
K850338 — EMERGENCY ROOM PACK1985-03-25
K850339 — SPECIAL PROCEDURES PACK1985-03-12
K850341 — CARDIOVASCULAR SET UP1985-02-25
K840620 — TPN/CVP DRESSING CHANGE KIT1984-05-30

Adverse events under product code DRE

product code DRE

Death: 100
Injury: 832
Malfunction: 597
Other: 3
Total: 1,532

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.