SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA— 510(k) K102101

Name: FDA 510(k) clearance K102101
Creator: U.S. Food and Drug Administration
Published: 2011-01-26

Substantially Equivalent

Surgivision, Inc.

FDA 510(k) clearance K102101 for SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA, Substantially Equivalent on 2011-01-26. Applicant: Surgivision, Inc.. Device class: 1.

Clearance details

Applicant: Surgivision, Inc.
Product code: Code HCD
Device class: Class 1
Regulation: 21 CFR 882.4060
Advisory panel: Neurology
Date received: 2010-07-27
Decision date: 2011-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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