510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K014075Substantially Equivalent

Bmc Coaxial Injectable Catheter, Model Cic 38/145 and Cic 35/145

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

K014075 is the FDA 510(k) clearance record for BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145, a class II device, cleared for Baylis Medical Co., Inc. on under FDA product code DQX (Wire, Guide, Catheter). FDA records list 53 510(k) clearances for Baylis Medical Co., Inc., from to . As of , FDA records show 2 recalls naming K014075.

Clearance record

Decision date
Received
(86 days to decision)
Product code
DQX Wire, Guide, Catheter
Regulation
21 CFR 870.1330
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 DQX

Trailing 12 months
12 clearances under product code DQX in the twelve months to October 2026, January 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DQX, trailing twelve months
MonthClearances
November 20251
December 20250
January 20263
February 20260
March 20263
April 20260
May 20261
June 20260
July 20262
August 20260
September 20262
October 20260