FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LimFlow ARC
K Number: K251376
·
Decision May 31, 2025
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
56
Applicant Total
6
Review Days
29
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Basic Information
- Device Name
- LimFlow ARC
- K Number
- K251376
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- LimFlow, Inc.
- Date Received
- May 2, 2025
- Decision Date
- May 31, 2025
- Product Code
- PDU
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PDU | Catheter For Crossing Total Occlusions | FDA class 2 | Cardiovascular |
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Other Clearances by LimFlow, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K260188 | LimFlow Vector | Mar 18, 2026 | Substantially Equivalent |
| K242776 | LimFlow V-Ceiver | Feb 14, 2025 | Substantially Equivalent |
| K221902 | LimFlow Vector | Dec 21, 2022 | Substantially Equivalent |
| K221541 | LimFlow ARC | Aug 31, 2022 | Substantially Equivalent |
| K222083 | LimFlow V-Ceiver | Aug 9, 2022 | Substantially Equivalent |