Cleared Special

PENTARAY? NAV ECO High Density Mapping Catheter, DECANAV? Mapping Catheter, Webster? CS Catheter with Auto ID, Webster? CS Catheter with EZ Steer Technology, Webster? CS Catheter with EZ Steer Technology with Auto ID

K231312 · Biosense Webster, Inc. · Cardiovascular

Jul 2023

Decision

66d

Days

Class 2

Risk

About This 510(k) Submission

K231312 is an FDA 510(k) clearance for the PENTARAY? NAV ECO High Density Mapping Catheter, DECANAV? Mapping Catheter, Webster? CS Catheter with Auto ID, Webster? CS Catheter with EZ Steer Technology, Webster? CS Catheter with EZ Steer Technology with Auto ID, a Catheter, Intracardiac Mapping, High-density Array (Class II — Special Controls, product code MTD), submitted by Biosense Webster, Inc. (Irvine, US). The FDA issued a Cleared decision on July 10, 2023, 66 days after receiving the submission on May 5, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1220.

Submission Details

510(k) Number	K231312 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 05, 2023
Decision Date	July 10, 2023
Days to Decision	66 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF