Cleared Special

K133999 - DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
(FDA 510(k) Clearance)

K133999 · Cardiovascular Systems, Inc. · Cardiovascular

Feb 2014

Decision

63d

Days

Class 2

Risk

K133999 is an FDA 510(k) clearance for the DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM. This device is classified as a Catheter, Peripheral, Atherectomy (Class II — Special Controls, product code MCW).

Submitted by Cardiovascular Systems, Inc. (Saint Paul, US). The FDA issued a Cleared decision on February 28, 2014, 63 days after receiving the submission on December 27, 2013.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4875.

Submission Details

510(k) Number	K133999 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 27, 2013
Decision Date	February 28, 2014
Days to Decision	63 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF