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TAPAS® Catheter

FDA UDI

Class II (US FDA UDI)

by Thermopeutix, Inc.

Identity

Trade Name
TAPAS® Catheter FDA UDI
Generic Name
Intravascular occluding balloon catheter, image-guided FDA UDI
Device Name
The TAPAS® Catheter consists of a two concentric tubular shafts (proximal occlusion balloon and distal occlusion balloon, POB and DOB, respectively) and is used to infuse diagnostic and therapeutic agents to selected regions, as well as direct arterial blood or other solutions to a specific region or organ. The proximal infusion lumen (Red) may be accessed using external devices connected to this lumen. There are three additional smaller lumens: one lumen is used for inflation of the balloon on the DOB; one lumen is used for inflation of the balloon on the POB; and one lumen permits pressure monitoring (Yellow) distal to the proximal occlusion balloon. The simultaneous inflation of the balloons may isolate a target region within a vessel and allow the infusion of a fluid agent into the vascular region of interest. The catheter is supplied with heparin in the hydrophilic coating. FDA UDI
Model / Reference
91-1045 FDA UDI
Description
The TAPAS® Catheter consists of a two concentric tubular shafts (proximal occlusion balloon and distal occlusion balloon, POB and DOB, respectively) and is used to infuse diagnostic and therapeutic agents to selected regions, as well as direct arterial blood or other solutions to a specific region or organ. The proximal infusion lumen (Red) may be accessed using external devices connected to this lumen. There are three additional smaller lumens: one lumen is used for inflation of the balloon on the DOB; one lumen is used for inflation of the balloon on the POB; and one lumen permits pressure monitoring (Yellow) distal to the proximal occlusion balloon. The simultaneous inflation of the balloons may isolate a target region within a vessel and allow the infusion of a fluid agent into the vascular region of interest. The catheter is supplied with heparin in the hydrophilic coating. FDA UDI

Identifiers

Primary DI / UDI-DI
M7819110451 FDA UDI
510(k) Number
K112219 FDA UDI
FDA Product Code
MJN FDA UDI
GMDN Term
Intravascular occluding balloon catheter, image-guided FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4450 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Intravascular occluding balloon catheter, image-guided

TAPAS® Catheter by Thermopeutix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intravascular occluding balloon catheter, image-guided.

Cleared under the same submission

K112219 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Thermopeutix, Inc.

Sources (1)

  • FDA UDI c2e681c8-cfdc-4c35-b6b9-b81f9ff52e0b 37 fields · synced May 30, 2026