510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K013919Substantially Equivalent

Torflex Transseptal Guiding Sheath

Baylis Medical Co., Inc., Mississauga, Ontario, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013919 is the FDA 510(k) clearance record for TORFLEX TRANSSEPTAL GUIDING SHEATH, a class I device, cleared for Baylis Medical Co., Inc. on under FDA product code DBY (Fab, Rhodamine, Antigen, Antiserum, Control). FDA records list 53 510(k) clearances for Baylis Medical Co., Inc., from to . As of , FDA records show one recall naming K013919.

Clearance record

Decision date
Received
(87 days to decision)
Product code
DBY Fab, Rhodamine, Antigen, Antiserum, Control
Regulation
21 CFR 866.5520
Device class
Class I
Review panel
Immunology
Applicant
Baylis Medical Co., Inc. 5160 Explorer Dr., Unit 33, Mississauga, Ontario, CA
510(k) summary
Statement
Third party review
No

Clearances, product code DBY

Trailing 12 months

FDA records hold no clearances under product code DBY in the trailing twelve months.

FDA records show no clearances under product code DBY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DBY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260