Cleared Traditional

Sniper Infusion Catheter with Balloon Occlusion

K180904 · Embolx, Inc. · Cardiovascular

Jun 2018

Decision

63d

Days

Class 2

Risk

About This 510(k) Submission

K180904 is an FDA 510(k) clearance for the Sniper Infusion Catheter with Balloon Occlusion, a Catheter, Intravascular Occluding, Temporary (Class II — Special Controls, product code MJN), submitted by Embolx, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on June 8, 2018, 63 days after receiving the submission on April 6, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4450.

Submission Details

510(k) Number	K180904 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 06, 2018
Decision Date	June 08, 2018
Days to Decision	63 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF