Identity
- Trade Name
- TriNav FLX Infusion System FDA UDI
- Generic Name
- Peripheral vascular intervention infusion catheter FDA UDI
- Device Name
- 150cm 0.021" Microcatheter w/ 1.5-3.5mm Expandable Tip FDA UDI
- Model / Reference
- FLX-21150-35 FDA UDI
- Description
- 150cm 0.021" Microcatheter w/ 1.5-3.5mm Expandable Tip FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857136004286 FDA UDI
- 510(k) Number
- K180677 FDA UDI
- FDA Product Code
- DQO FDA UDI
- GMDN Term
- Peripheral vascular intervention infusion catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1200 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
Dimensions & Sizes
- Size
- Catheter Inner Diameter — .021 Inch FDA UDICatheter Working Length — 150 Centimeter FDA UDICatheter Gauge — 2.4 French FDA UDI
Category: Peripheral vascular intervention infusion catheter
TriNav FLX Infusion System by Surefire Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral vascular intervention infusion catheter.
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- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- Introcan Safety ® 2 — B. BRAUN MEDICAL INC. · Class II
- Fountain® — Merit Medical Systems, Inc. · Class II
Cleared under the same submission
K180677 also covers:
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
- Surefire Medical, Inc.
Sources (1)
- FDA UDI cd3fb462-2dfc-42d8-8e27-63a977d4881b 35 fields · synced May 30, 2026