Cleared Special

K131092 - STEALTH 360 ORBITAL PAD SYSTEM
(FDA 510(k) Clearance)

K131092 · Cardio Systems, Inc. · Cardiovascular

Jun 2013

Decision

67d

Days

Class 2

Risk

K131092 is an FDA 510(k) clearance for the STEALTH 360 ORBITAL PAD SYSTEM. This device is classified as 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 June 24, 2013, 67 days after receiving the submission on April 18, 2013.

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

Submission Details

510(k) Number	K131092 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 18, 2013
Decision Date	June 24, 2013
Days to Decision	67 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF