Cleared Traditional

Pantera Pro

K160985 · Biotronik, Inc. · Cardiovascular
Oct 2016
Decision
182d
Days
Class 2
Risk

About This 510(k) Submission

K160985 is an FDA 510(k) clearance for the Pantera Pro, a Catheters, Transluminal Coronary Angioplasty, Percutaneous (Class II — Special Controls, product code LOX), submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on October 7, 2016, 182 days after receiving the submission on April 8, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5100.

Submission Details

510(k) Number K160985 FDA.gov
FDA Decision Cleared SESE
Date Received April 08, 2016
Decision Date October 07, 2016
Days to Decision 182 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code LOX — Catheters, Transluminal Coronary Angioplasty, Percutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5100
Definition A Ptca Catheter Is A Device That Operates On The Principle Of Hydraulic Pressurization Applied Through An Inflatable Balloon Attached To The Distal End.

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