FDA.reportPublic FDA data

ProTrack Microcatheter

Primary DI
07540299000181
Brand
ProTrack Microcatheter
Company
Baylis Medical Technologies Inc
Model
CIC35-145
Published
2023-06-26
Public version status
Update
Distribution status
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
00685447000617PreviousGS10
07540299000181PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00685447000617006854470006176854470006170685447000617
07540299000181075402990001817540299000181

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular intervention infusion catheterA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length145Centimeter
Outer Diameter0.035Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
905-948-5800info@baylismedtech.com

Regulatory Flags#

DUNS number
240389677
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540299000426PowerWire 14 Radiofrequency Guidewire KitPW14-190-S2025-12-04
07540299000433PowerWire 14 Radiofrequency Guidewire KitPW14-300-S2025-12-04
07540299000471PowerWire 14 Radiofrequency Guidewire KitPW14-190-20A2025-12-04
07540299000488PowerWire 14 Radiofrequency Guidewire KitPW14-300-20A2025-12-04
07540299000440 PowerWire Pulse RF Guidewire KitPTK35-250-08-6S2024-09-27
07540299000457 PowerWire Pulse RF Guidewire KitPTK35-250-10-6S2024-09-27
07540299000464 PowerWire Pulse RF Guidewire KitPTK35-250-12-6S2024-09-27
07540299000020AnchorKnot SutureASU-0-W-CL2022-11-16
07540299000037AnchorKnot SutureASU-2-0-WB-CL2022-11-16
07540299000044AnchorKnot SutureASU-2-0-W-CL2022-11-16
07540299000051AnchorKnot SutureASU-2-WB-CL2022-11-16
07540299000068AnchorKnot SutureASU-2-W-CL2022-11-16
07540299000013AnchorKnot SutureASU-0-WB-CL2022-11-16
07540299000075AnchorKnot SutureASU-0-WB-LR2022-11-16
07540299000082AnchorKnot SutureASU-0-W-LR2022-11-16
07540299000099AnchorKnot SutureASU-2-0-WB-LR2022-11-16
07540299000105AnchorKnot SutureASU-2-0-W-LR2022-11-16
07540299000112AnchorKnot SutureASU-2-WB-LR2022-11-16
07540299000129AnchorKnot SutureASU-2-W-LR2022-11-16
07540299000136AnchorKnot Suture Passer (2-0) PSZ-400-3052022-11-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07640142811343SET Aspirex™ S 8F 110cmStraub Medical AGDQX2022-06-30
07640142811350SET Aspirex™ S 10F 110cmStraub Medical AGDQX2022-06-30
07640142811855SET Rotarex™S 6 F x 110 cmStraub Medical AGDQX2022-05-04
07640142811862SET Rotarex™S 6 F x 135 cm Straub Medical AGDQX2022-05-04
07640142811879SET Rotarex™S 8 F x 85 cm Straub Medical AGDQX2022-05-04
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07640142810599SET Rotarex®S 8F 85cm (Straub Medical®)Straub Medical AGDQX2020-01-31
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