Cleared Traditional

K153530 - Bridge Occlusion Balloon
(FDA 510(k) Clearance)

K153530 · Spectranetics, Inc. · Cardiovascular

Feb 2016

Decision

58d

Days

Class 2

Risk

K153530 is an FDA 510(k) clearance for the Bridge Occlusion Balloon, a Catheter, Intravascular Occluding, Temporary (Class II — Special Controls, product code MJN), submitted by Spectranetics, Inc. (Colorado Springs, US). The FDA issued a Cleared decision on February 5, 2016, 58 days after receiving the submission on December 9, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4450.

Submission Details

510(k) Number	K153530 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 09, 2015
Decision Date	February 05, 2016
Days to Decision	58 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF