510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K080425Substantially Equivalent

Cs Refstar Catheter (D- and F-Curves), Models D-1285-01 and D-1285-02

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

K080425 is the FDA 510(k) clearance record for CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02, a class II device, cleared for Biosense Webster, Inc. on under FDA product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording). FDA records list 76 510(k) clearances for Biosense Webster, Inc., from to . As of , FDA records show no recalls naming K080425.

Clearance record

Decision date
Received
(68 days to decision)
Product code
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
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 DRF

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