510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K031949Substantially Equivalent

Toronto RF Septostomy Catheter, Model Tsc-50-75

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

K031949 is the FDA 510(k) clearance record for TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75, a class II device, cleared for Baylis Medical Co., Inc. on under FDA product code DXF (Catheter, Septostomy). FDA records list 53 510(k) clearances for Baylis Medical Co., Inc., from to . As of , FDA records show no recalls naming K031949.

Clearance record

Decision date
Received
(169 days to decision)
Product code
DXF Catheter, Septostomy
Regulation
21 CFR 870.5175
Device class
Class II
Review panel
Cardiovascular
Applicant
Baylis Medical Co., Inc. 5160 Explorer Dr., Unit 33, Mississauga, Ontario, CA
510(k) summary
Statement
Third party review
No

Clearances, product code DXF

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