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LimFlow ARC
FDA UDIFDA 510(k)Class II (US FDA UDI)
510(k) K251376
by Limflow Inc.
Identity
- Trade Name
- LimFlow ARC FDA UDI
- Generic Name
- Vascular guide-catheter, single-use FDA UDI
- Device Name
- The LimFlow ARC is intended to facilitate placement and positioning of guidewires and catheters within the peripheral vasculature. The LimFlow ARC is not intended for use in the coronary or cerebral vasculature FDA UDI
- Model / Reference
- AC-US-23 FDA UDI
- Description
- The LimFlow ARC is intended to facilitate placement and positioning of guidewires and catheters within the peripheral vasculature. The LimFlow ARC is not intended for use in the coronary or cerebral vasculature FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850041730158 FDA UDI
- FDA Product Code
- PDU FDA UDI
- GMDN Term
- Vascular guide-catheter, single-use 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
No
FDA UDI
Category: Vascular guide-catheter, single-use
LimFlow ARC by Limflow Inc. — Class II — FDA_510K — listed in FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K221541 | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K251376 | Class II | Active |
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Manufacturer
- Manufacturer
- Limflow Inc.
- FDA Applicant
- LimFlow, Inc.
Sources (2)
- FDA UDI 2d5c48ab-c7cf-411c-b32b-f07e34164f25 57 fields · synced Jun 18, 2026
- FDA 510(k) K221541 1 fields · synced Jun 5, 2026