AccessGUDID - DEVICE: TAPAS® Catheter (M78110445451)

GUDID

Device Identifier (DI) Information

Brand Name: TAPAS® Catheter
Version or Model: 104-4545
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Thermopeutix, Inc.

Primary DI Number: M78110445451
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 138648154 *Terms of Use

Device 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 hydrophilic coating.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
32584	Intravascular occluding balloon catheter, image-guided	A non-powered flexible tube with an inflatable balloon(s) at the distal end intended to be introduced short-term under image guidance to temporarily block a blood vessel. It may be used for arteriography, selective angiography, preoperative occlusion, peripheral and intracranial vasculature occlusion, emergency control of haemorrhage, to treat aneurysms, chemotherapeutic drug infusion, and renal opacification procedures. It may have a dual- or multi-lumen design for balloon inflation, introduction over a guidewire, infusion of contrast medium, or delivery of a smaller catheter or embolic agents; some types have graduated markings to assist insertion. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MJN	Catheter, Intravascular Occluding, Temporary

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K112219	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between -29 and 55 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Sheath Compatibility: 7 Fr
Device Size Text, specify: Treatment Length: 15 mm - 300 mm
Device Size Text, specify: Distal Balloon Useable Shaft Length: 165 cm
Device Size Text, specify: Proximal Balloon Shaft Length: 135 cm
Device Size Text, specify: Distal Balloon Diameter: 4.5 mm
Device Size Text, specify: Proximal Balloon Diameter: 4.5 mm

Device Record Status

Public Device Record Key: 39b38877-fef4-4277-9739-b169fe6bef64
Public Version Date: December 04, 2023
Public Version Number: 5
DI Record Publish Date: September 15, 2016