BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145

Wire, Guide, Catheter

BAYLIS MEDICAL CO., INC.

The following data is part of a premarket notification filed by Baylis Medical Co., Inc. with the FDA for Bmc Coaxial Injectable Catheter, Model Cic 38/145 And Cic 35/145.

Pre-market Notification Details

• Device ID: K014075
• 510k Number: K014075
• Device Name: BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145
• Classification: Wire, Guide, Catheter
• Applicant: BAYLIS MEDICAL CO., INC. 5160 EXPLORER DRIVE, UNIT 33 Mississauga, Ontario, CA L4w-4t7
• Contact: Kris Shah
• Correspondent: Kris Shah; BAYLIS MEDICAL CO., INC. 5160 EXPLORER DRIVE, UNIT 33 Mississauga, Ontario, CA L4w-4t7
• Product Code: DQX
• CFR Regulation Number: 870.1330 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-12-11
• Decision Date: 2002-03-07

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00685447000624	K014075	000
00685447000617	K014075	000
07540299000198	K014075	000
07540299000181	K014075	000