510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K072202Substantially Equivalent

Carto 3 Navigation System (Model:fg-5400-00), Carto 3 External Reference Patches (Model:d-1283-01)

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

K072202 is the FDA 510(k) clearance record for CARTO 3 NAVIGATION SYSTEM (MODEL:FG-5400-00), CARTO 3 EXTERNAL REFERENCE PATCHES (MODEL:D-1283-01), 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 K072202.

Clearance record

Decision date
Received
(103 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. 3333 Diamond Canyon Rd., Diamond Bar CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DQK

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