TORQMAX SHEATH GRIP ACCESSORY— 510(k) K093257

Name: FDA 510(k) clearance K093257
Creator: U.S. Food and Drug Administration
Published: 2010-03-26

Substantially Equivalent

Spectranetics Corp.

FDA 510(k) clearance K093257 for TORQMAX SHEATH GRIP ACCESSORY, Substantially Equivalent on 2010-03-26. Applicant: Spectranetics Corp.. Device class: 2.

Clearance details

Applicant: Spectranetics Corp.
Product code: Code OFC
Device class: Class 2
Regulation: 21 CFR 870.1340
Advisory panel: Cardiovascular
Date received: 2009-10-19
Decision date: 2010-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Colorado Springs, CO, US

Download summary PDF View on FDA.gov ↗

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