FDA.reportPublic FDA data

Telemark™ Microcatheter

Primary DI
05391525786452
Brand
Telemark™ Microcatheter
Company
CREAGH MEDICAL LIMITED
Model
SURMC135
Device description
The Surmodics Microcatheter is a sterile, single use, percutaneous device intended to provide support to facilitate the placementof guidewires in the coronary and peripheral vasculature. Additionally, the microcatheter can be used for contrast media injection.The catheter is a single-lumen microcatheter with a 1.9 Fr distal outer diameter, a 2.6 Fr proximal outer diameter and iscompatible with a 0.014” guidewire. The proximal end of the catheter shaft has a larger inner diameter, outer diameter and wallthickness and tapers to the distal end. The catheter is available in lengths of 135 cm and 150 cm in length to facilitate access tovarious target sites.
Published
2021-07-08
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

Product Codes#

Code, Name table
CodeName
DQYCatheter, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391525786452PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391525786452053915257864525391525786452

GMDN Terms#

Term, Definition table
TermDefinition
Vascular microcatheterA sterile, small-diameter, single-lumen, flexible tube designed for the controlled infusion of fluids (e.g., thrombolytics, diagnostic contrast media) into superselective small vessels (including intracranial, peripheral, or occluded coronary vasculature) for angiography/treatment, and typically also for the delivery of devices (e.g., embolization implants, guidewires) into tortuous vessels or across tight lesions. It may include an ultrasound transducer, a thermal sensor, and a hole for guidewire placement located at the distal tip. It is not a guide-catheter (i.e., is not intended to deliver other catheters or therapeutic leads directly through its lumen). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length135Centimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
985021909
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391525787480Advance Serenity® 18 Hydrophilic PTA Balloon Dilatation CatheterSER18-135-50-2202025-03-14
05391525787497Advance Serenity® 18 Hydrophilic PTA Balloon Dilatation CatheterSER18-135-60-2202025-03-14
05391525787503Advance Serenity® 18 Hydrophilic PTA Balloon Dilatation CatheterSER18-135-70-2202025-03-14
05391525785912Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-200202021-10-20
05391525785929Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-200402021-10-20
05391525785936Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-200602021-10-20
05391525785943Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-200802021-10-20
05391525785950Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-201002021-10-20
05391525785967Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-201202021-10-20
05391525785974Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-201502021-10-20
05391525785981Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-202202021-10-20
05391525785998Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-250202021-10-20
05391525786001Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-250402021-10-20
05391525786018Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-250602021-10-20
05391525786025Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-250802021-10-20
05391525786032Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-251002021-10-20
05391525786049Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-251202021-10-20
05391525786056Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-251502021-10-20
05391525786063Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-252202021-10-20
05391525786070Sublime™ Radial Access 018 RX PTA Dilatation CatheterSRA-DC18-300202021-10-20

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Primary DI, Brand, Company table
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