FDA.reportPublic FDA data

ProTrack Microcatheter

Primary DI
00685447000624
Brand
ProTrack Microcatheter
Company
Baylis Médicale Cie Inc
Model
CIC 38-145
Published
2016-08-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQXWire, Guide, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K014075000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K014075000BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145Baylis Medical Co., Inc.2002-03-07DQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00685447000624PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00685447000624006854470006246854470006240685447000624

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular infusion catheterA sterile, flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature; some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced [e.g., through a guide catheter, or over-the-wire (OTW)], 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 microcatheter for access into superselective small vessels. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length145Centimeter
Outer Diameter0.038Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5144889801info@baylismedical.com

Regulatory Flags#

DUNS number
249225954
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00685447018841VersaCross Connect Transseptal DilatorVXA12-84-35-PS-D1NA2023-08-15
00685447010487VersaCross Connect Transseptal Dilator VXA12-85-35-WM-D02022-05-19
00685447010531VersaCross Connect Transseptal DilatorVXA12-85-35-WM-D1NA2022-05-19
00685447005247VersaCross Large Access Transseptal DilatorVLA125-35-67-D0NA2021-06-10
00685447005254VersaCross Large Access Transseptal DilatorVLA125-35-67-D1NA2021-06-10
00685447005261VersaCross Large Access Transseptal DilatorVLA125-35-85-D0NA2021-06-10
00685447005278VersaCross Large Access Transseptal DilatorVLA125-35-85-D1NA2021-06-10
00685447005735VersaCross Steerable SheathVST85-35-BD-71L-D0NA2021-04-08
00685447005759VersaCross Steerable SheathVST85-35-BD-71M-D0NA2021-04-08
00685447005766VersaCross Steerable SheathVST85-35-BD-71M-D1NA2021-04-08
00685447005780VersaCross Steerable SheathVST85-35-BD-71S-D1NA2021-04-08
00685447003380VersaCross Transseptal SheathVXS85-35-63-45-D02019-06-26
00685447003397VersaCross Transseptal SheathVXS85-35-63-55-D02019-06-26
00685447003281VersaCross RF WireVXW-35-180-J2019-05-01
00685447003298VersaCross RF WireVXW-35-180-P2019-05-01
00685447003304VersaCross RF WireVXW-35-230-J2019-05-01
00685447003311VersaCross RF WireVXW-35-230-P2019-05-01
00685447000938RFP-100A Connector CableRFX-BAY-OTW-12-SU2016-08-15
00685447001027Adult Dispersive ElectrodeRFA-GP-BAY2017-02-03
00685447011774VersaCross Access SolutionVXSK0026NA2022-07-08

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Primary DI, Brand, Company table
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