Twin-Pass® Torque dual access catheter

GUDID M20652010

The Twin-Pass catheter is intended to access discrete regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and to subselectively infuse/deliver diagnostic and therapeutic agents.

Vascular Solutions, Inc.

Peripheral vascular infusion catheter
Primary Device IDM20652010
NIH Device Record Key3c2d1e04-f94b-4f09-9a3e-baadafc7cd51
Commercial Distribution StatusIn Commercial Distribution
Brand NameTwin-Pass® Torque dual access catheter
Version Model Number5201
Company DUNS008999906
Company NameVascular Solutions, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com
Phone888-240-6001
Emailcustomerservice@vasc.com

Device Dimensions

Length135 Centimeter
Catheter Gauge3.5 French
Length135 Centimeter
Catheter Gauge3.5 French
Length135 Centimeter
Catheter Gauge3.5 French
Length135 Centimeter
Catheter Gauge3.5 French
Length135 Centimeter
Catheter Gauge3.5 French
Length135 Centimeter
Catheter Gauge3.5 French
Length135 Centimeter
Catheter Gauge3.5 French
Length135 Centimeter
Catheter Gauge3.5 French
Length135 Centimeter
Catheter Gauge3.5 French
Length135 Centimeter
Catheter Gauge3.5 French
Length135 Centimeter
Catheter Gauge3.5 French
Length135 Centimeter
Catheter Gauge3.5 French
Length135 Centimeter
Catheter Gauge3.5 French
Length135 Centimeter
Catheter Gauge3.5 French
Length135 Centimeter
Catheter Gauge3.5 French
Length135 Centimeter
Catheter Gauge3.5 French
Length135 Centimeter
Catheter Gauge3.5 French
Length135 Centimeter
Catheter Gauge3.5 French
Length135 Centimeter
Catheter Gauge3.5 French
Length135 Centimeter
Catheter Gauge3.5 French
Length135 Centimeter
Catheter Gauge3.5 French
Length135 Centimeter
Catheter Gauge3.5 French
Length135 Centimeter
Catheter Gauge3.5 French
Length135 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM20652010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQYCatheter, Percutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-11-11
Device Publish Date2017-02-13

Devices Manufactured by Vascular Solutions, Inc.

M20677101 - Vascular Solutions Custom Access Kit2023-06-09
M20677141 - Vascular Solutions Custom Access Kit2023-06-09 The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following
M20677181 - Vascular Solutions Custom Access Kit2023-06-09 The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following
M20677191 - Vascular Solutions Custom Access Kit2023-06-09 The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following
M20677201 - Vascular Solutions Custom Access Kit2023-06-09 The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following
M20677211 - Vascular Solutions Custom Access Kit2023-06-09 The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following
M20677221 - Vascular Solutions Custom Access Kit2023-06-09 The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following
M20677231 - Vascular Solutions Custom Access Kit2023-06-09 The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following

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