Cleared Traditional

MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002

K071140 · Top Spins, Inc. · Radiology

Jun 2007

Decision

44d

Days

Class 1

Risk

About This 510(k) Submission

K071140 is an FDA 510(k) clearance for the MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002, a Tourniquet, Pneumatic (Class I — General Controls, product code KCY), submitted by Top Spins, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on June 7, 2007, 44 days after receiving the submission on April 24, 2007. This device falls under the Radiology review panel. Regulated under 21 CFR 878.5910.

Submission Details

510(k) Number	K071140 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 24, 2007
Decision Date	June 07, 2007
Days to Decision	44 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement