DEVICE: Turnpike® LP catheter (M20656390)

Device Identifier (DI) Information

Turnpike® LP catheter
5639
Not in Commercial Distribution

Vascular Solutions, Inc.
M20656390
HIBCC
December 20, 2021
1
008999906 *Terms of Use
The Turnpike catheters are intended to be used to access discrete regions of the coronary and/or peripheral vasculature. They may be used to facilitate placement and exchange of guidewires and to subselectively infuse/deliver diagnostic and therapeutic agents.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
17846 Vascular guide-catheter, single-use
A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DQY Catheter, Percutaneous
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Length: 150 Centimeter
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Device Record Status

9ba03af2-eb1f-4cc6-ba15-4a7d69019290
June 06, 2023
9
September 05, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
888-240-6001
customerservice@vasc.com
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