QUART ARTERIAL FILTER, MODEL HBF 140— 510(k) K001787

Name: FDA 510(k) clearance K001787
Creator: U.S. Food and Drug Administration
Published: 2000-06-30

Substantially Equivalent

Jostra Medizintechnik AG

FDA 510(k) clearance K001787 for QUART ARTERIAL FILTER, MODEL HBF 140, Substantially Equivalent on 2000-06-30. Applicant: Jostra Medizintechnik AG. Device class: 2.

Clearance details

Applicant: Jostra Medizintechnik AG
Product code: Code DTM
Device class: Class 2
Regulation: 21 CFR 870.4260
Advisory panel: Cardiovascular
Date received: 2000-06-13
Decision date: 2000-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

Download summary PDF View on FDA.gov ↗

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