Cleared Traditional

Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D

K160335 · St Jude Medical · Cardiovascular

Dec 2016

Decision

309d

Days

Class 2

Risk

About This 510(k) Submission

K160335 is an FDA 510(k) clearance for the Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D, a Catheter, Electrode Recording, Or Probe, Electrode Recording (Class II — Special Controls, product code DRF), submitted by St Jude Medical (Plymouth, US). The FDA issued a Cleared decision on December 13, 2016, 309 days after receiving the submission on February 8, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1220.

Submission Details

510(k) Number	K160335 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 08, 2016
Decision Date	December 13, 2016
Days to Decision	309 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	DRF — Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1220