HEARTPORT ENDOAORTIC CLAMP CATHETER— 510(k) K974175

Name: FDA 510(k) clearance K974175
Creator: U.S. Food and Drug Administration
Published: 1997-12-16

Substantially Equivalent

Heartport, Inc.

FDA 510(k) clearance K974175 for HEARTPORT ENDOAORTIC CLAMP CATHETER, Substantially Equivalent on 1997-12-16. Applicant: Heartport, Inc.. Device class: 2.

Clearance details

Applicant: Heartport, Inc.
Product code: Code DWZ
Device class: Class 2
Regulation: 21 CFR 870.4075
Advisory panel: Cardiovascular
Date received: 1997-11-06
Decision date: 1997-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.