THE OMNIGUIDE GUIDING CATHETER WITH BALLOON— 510(k) K945963

Name: FDA 510(k) clearance K945963
Creator: U.S. Food and Drug Administration
Published: 1995-02-08

Substantially Equivalent

Micro Interventional Systems, Inc.

FDA 510(k) clearance K945963 for THE OMNIGUIDE GUIDING CATHETER WITH BALLOON, Substantially Equivalent on 1995-02-08. Applicant: Micro Interventional Systems, Inc.. Device class: 2.

Clearance details

Applicant: Micro Interventional Systems, Inc.
Product code: Code DQT
Device class: Class 2
Regulation: 21 CFR 870.1370
Advisory panel: Cardiovascular
Date received: 1994-12-07
Decision date: 1995-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

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