NEGATIVE PRESSURE ARTERIAL LINE CAT. NO: 03-9630— 510(k) K903021

Name: FDA 510(k) clearance K903021
Creator: U.S. Food and Drug Administration
Published: 1990-08-14

Substantially Equivalent

National Medical Care, Medical Products Div., Inc.

FDA 510(k) clearance K903021 for NEGATIVE PRESSURE ARTERIAL LINE CAT. NO: 03-9630, Substantially Equivalent on 1990-08-14. Applicant: National Medical Care, Medical Products Div., Inc.. Device class: 2.

Clearance details

Applicant: National Medical Care, Medical Products Div., Inc.
Product code: Code FJK
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1990-07-11
Decision date: 1990-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockleigh, NJ, US

Download summary PDF View on FDA.gov ↗

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K930843 — RAPID DISCONNECT Y-SET, CAT. NO. 48-70001994-08-31
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Adverse events under product code FJK

product code FJK

Death: 52
Malfunction: 3,430
Total: 3,482

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.