510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K231207Substantially Equivalent

CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)

Biosense Webster Inc, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K231207 is the FDA 510(k) clearance record for CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U), a class II device, cleared for Biosense Webster, Inc. on under FDA product code DQK (Computer, Diagnostic, Programmable). FDA records list 76 510(k) clearances for Biosense Webster, Inc., from to . As of , FDA records show no recalls naming K231207.

Clearance record

Decision date
Received
(133 days to decision)
Product code
DQK Computer, Diagnostic, Programmable
Regulation
21 CFR 870.1425
Device class
Class II
Review panel
Cardiovascular
Applicant
Biosense Webster, Inc. 31 Technology Dr., Suite 200, Irvine CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DQK

Trailing 12 months
25 clearances under product code DQK in the twelve months to October 2026, February 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code DQK, trailing twelve months
MonthClearances
November 20250
December 20254
January 20262
February 20265
March 20260
April 20263
May 20261
June 20263
July 20264
August 20262
September 20261
October 20260