510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001139Substantially Equivalent

Preface Guiding Sheath, Models 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M

Biosense Webster Inc, Diamond Bar CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K001139 is the FDA 510(k) clearance record for PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M, a class II device, cleared for Biosense Webster, Inc. on under FDA product code DYB (Introducer, Catheter). FDA records list 76 510(k) clearances for Biosense Webster, Inc., from to . As of , FDA records show 5 recalls naming K001139.

Clearance record

Decision date
Received
(30 days to decision)
Product code
DYB Introducer, Catheter
Regulation
21 CFR 870.1340
Device class
Class II
Review panel
Cardiovascular
Applicant
Biosense Webster, Inc. 3333 Diamond Canyon Rd., Diamond Bar CA
510(k) summary
Summary
Third party review
No

Clearances, product code DYB

Trailing 12 months
18 clearances under product code DYB in the twelve months to October 2026, April 2026 the highest month at 7.
Show the numbers
Monthly 510(k) clearances under FDA product code DYB, trailing twelve months
MonthClearances
November 20250
December 20252
January 20261
February 20262
March 20261
April 20267
May 20260
June 20263
July 20262
August 20260
September 20260
October 20260