ProTrack Microcatheter

Basic Information

• Brand Name: ProTrack Microcatheter
• Primary DI: 07540299000198
• Version / Model: CIC38-145
• Company Name: Baylis Medical Technologies Inc
• Labeler DUNS: 240389677
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-26
• Public Version: 2
• Public Version Date: 2023-10-23
• Public Version Status: Update
• Public Device Record Key: 71260ae2-8c28-4192-b339-d5713c8478e1

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DQX	Wire, Guide, Catheter	Cardiovascular	870.1330	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32151	Peripheral vascular intervention infusion catheter	A flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature during a cardiovascular procedure (e.g., delivery of an antithrombotic agent); some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor superselective small vessel microcatheter. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07540299000198	GS1
Previous	00685447000624	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K014075	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Body ID = 0.027 inch, Tapered end ID = 0.025 inch
Outer Diameter	0.038	Inch
Length	145	Centimeter