Identity
- Trade Name
- Primi™ Support Catheter FDA UDI
- Generic Name
- Peripheral vascular intervention infusion catheter FDA UDI
- Device Name
- The Primi™ Support Catheter is a single lumen catheter with an integrated spine wire and guidewire lumen designed for use in the peripheral vasculature. The catheter provides support for guidewires during interventional procedures and allows for the exchange of one distally located guidewire for another while maintaining access to the distal vasculature. The Primi™ Support Catheter has a hydrophilic coating on the distal portion of the catheter, and is compatible with various guidewire diameters and lengths. The catheter has a single radiopaque marker band located at the distal tip of the catheter. FDA UDI
- Model / Reference
- P35-120-150 FDA UDI
- Description
- The Primi™ Support Catheter is a single lumen catheter with an integrated spine wire and guidewire lumen designed for use in the peripheral vasculature. The catheter provides support for guidewires during interventional procedures and allows for the exchange of one distally located guidewire for another while maintaining access to the distal vasculature. The Primi™ Support Catheter has a hydrophilic coating on the distal portion of the catheter, and is compatible with various guidewire diameters and lengths. The catheter has a single radiopaque marker band located at the distal tip of the catheter. FDA UDI
Identifiers
- Primary DI / UDI-DI
- M781P351201501 FDA UDI
- 510(k) Number
- K130850 FDA UDI
- FDA Product Code
- DQY FDA UDI
- GMDN Term
- Peripheral vascular intervention infusion catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1250 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: Peripheral vascular intervention infusion catheter
Primi™ Support Catheter by Thermopeutix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Peripheral vascular intervention infusion catheter.
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Cleared under the same submission
K130850 also covers:
- Primi™ Support Catheter — Thermopeutix, Inc.
- Primi™ Support Catheter — Thermopeutix, Inc.
- Primi™ Support Catheter — Thermopeutix, Inc.
- Primi™ Support Catheter — Thermopeutix, Inc.
- Primi™ Support Catheter — Thermopeutix, Inc.
- Primi™ Support Catheter — Thermopeutix, Inc.
- Primi™ Support Catheter — Thermopeutix, Inc.
- Primi™ Support Catheter — Thermopeutix, Inc.
- Primi™ Support Catheter — Thermopeutix, Inc.
- Primi™ Support Catheter — Thermopeutix, Inc.
- Primi™ Support Catheter — Thermopeutix, Inc.
- Primi™ Support Catheter — Thermopeutix, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Thermopeutix, Inc.
Sources (1)
- FDA UDI 6347e881-fda4-4577-91ca-537a1cfcce0e 37 fields · synced May 30, 2026