Duns Number:985021909
Device Description: The Surmodics Microcatheter is a sterile, single use, percutaneous device intended to prov 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.
Catalog Number
-
Brand Name
Telemark™ Microcatheter
Version/Model Number
SURMC150
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DQY
Product Code Name
Catheter, Percutaneous
Public Device Record Key
87e1bec6-92e1-469e-b406-e6edc23ccb16
Public Version Date
July 16, 2021
Public Version Number
1
DI Record Publish Date
July 08, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 500 |