ACT 11 MP VENTRICULAR CATHETER— 510(k) K013005

Name: FDA 510(k) clearance K013005
Creator: U.S. Food and Drug Administration
Published: 2002-03-08

Substantially Equivalent

Innerspace, Inc.

FDA 510(k) clearance K013005 for ACT 11 MP VENTRICULAR CATHETER, Substantially Equivalent on 2002-03-08. Applicant: Innerspace, Inc.. Device class: 2.

Clearance details

Applicant: Innerspace, Inc.
Product code: Code HCA
Device class: Class 2
Regulation: 21 CFR 882.4100
Advisory panel: Neurology
Date received: 2001-09-06
Decision date: 2002-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, 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.