Cleared Special

K081944 - MODIFICATION TO DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM
(FDA 510(k) Clearance)

K081944 · Cardio Systems, Inc. · Cardiovascular

Aug 2008

Decision

37d

Days

Class 2

Risk

K081944 is an FDA 510(k) clearance for the MODIFICATION TO DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM, a Catheter, Peripheral, Atherectomy (Class II — Special Controls, product code MCW), submitted by Cardio Systems, Inc. (Saint Paul, US). The FDA issued a Cleared decision on August 14, 2008, 37 days after receiving the submission on July 8, 2008. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4875.

Submission Details

510(k) Number	K081944 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 08, 2008
Decision Date	August 14, 2008
Days to Decision	37 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF