TAPAS® Catheter
Basic Information
- Brand Name
- TAPAS® Catheter
- Primary DI
- M78110480801
- Version / Model
- 104-8080
- Company Name
- Thermopeutix, Inc.
- Labeler DUNS
- 138648154
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-15
- Public Version
- 5
- Public Version Date
- 2023-12-04
- Public Version Status
- Update
- Public Device Record Key
- 1dab8d8a-004e-405d-92ce-186968a57933
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
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MJN | Catheter, Intravascular Occluding, Temporary | Cardiovascular | 870.4450 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M78110480801 | HIBCC |
Customer Contacts
- Phone
- 1-858-549-1760
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K112219 | 000 |
Device Sizes
| Type | Value | Unit | 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: 8.0 mm | ||
| Device Size Text, specify | Proximal Balloon Diameter: 8.0 mm |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -29 – 55 Degrees Celsius