510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K201288Substantially Equivalent

ExpanSure Large Access Transseptal Dilator

Baylis Medical Co., Inc., Mississauga, CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K201288 is the FDA 510(k) clearance record for ExpanSure Large Access Transseptal Dilator, a class II device, cleared for Baylis Medical Company, Inc. on under FDA product code DRE (Dilator, Vessel, For Percutaneous Catheterization). FDA records list 53 510(k) clearances for Baylis Medical Company, Inc., from to . As of , FDA records show no recalls naming K201288.

Clearance record

Decision date
Received
(29 days to decision)
Product code
DRE Dilator, Vessel, For Percutaneous Catheterization
Regulation
21 CFR 870.1310
Device class
Class II
Review panel
Cardiovascular
Applicant
Baylis Medical Company, Inc. 2580 Matheson Blvd. E., Mississauga, CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DRE

Trailing 12 months
2 clearances under product code DRE in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DRE, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260