510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K120425Substantially Equivalent

Pentaray Nav High-Density Mapping Catheter

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

K120425 is the FDA 510(k) clearance record for PENTARAY NAV HIGH-DENSITY MAPPING CATHETER, a class II device, cleared for Biosense Webster, Inc. on under FDA product code MTD (Catheter, Intracardiac Mapping, High-Density Array). FDA records list 76 510(k) clearances for Biosense Webster, Inc., from to . As of , FDA records show 5 recalls naming K120425.

Clearance record

Decision date
Received
(101 days to decision)
Product code
MTD Catheter, Intracardiac Mapping, High-Density Array
Regulation
21 CFR 870.1220
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 MTD

Trailing 12 months
2 clearances under product code MTD in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MTD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260