Tapas Catheter

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K112219

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: 91-8025 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: M7819180251 FDA UDI
510(k) Number: K112219 FDA 510(k)FDA UDI
FDA Product Code: MJN FDA 510(k)FDA UDI
GMDN Term: Intravascular occluding balloon catheter, image-guided FDA UDI

Classification

Device Class: Class II FDA 510(k)FDA UDI
Legislation / Framework: 21 CFR Part 870.4450 FDA 510(k)
Regulation Number: 870.4450 FDA 510(k)FDA UDI
Advisory Committee: Cardiovascular FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Tapas Catheter by Thermopeutix, Inc. — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K112219	Class II	Active

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Thermopeutix, Inc.

Sources (2)

FDA 510(k) K112219 24 fields · synced Jun 18, 2026
FDA UDI 592e51c1-1c83-4a80-b87f-639aaf3cca6f 37 fields · synced May 26, 2026