Cleared Special

K072748 - MODIFICATION TO: DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM
(FDA 510(k) Clearance)

K072748 · Cardiovascular Systems, Inc. · Cardiovascular

Nov 2007

Decision

43d

Days

Class 2

Risk

K072748 is an FDA 510(k) clearance for the MODIFICATION TO: DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM, a Catheter, Peripheral, Atherectomy (Class II — Special Controls, product code MCW), submitted by Cardiovascular Systems, Inc. (Plymouth, US). The FDA issued a Cleared decision on November 9, 2007, 43 days after receiving the submission on September 27, 2007. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4875.

Submission Details

510(k) Number	K072748 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 27, 2007
Decision Date	November 09, 2007
Days to Decision	43 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF