FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LimFlow Vector
K Number: K260188
·
Decision Mar 18, 2026
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
26
Applicant Total
6
Review Days
55
Basic Information
- Device Name
- LimFlow Vector
- K Number
- K260188
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.4885
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- LimFlow, Inc.
- Date Received
- January 22, 2026
- Decision Date
- March 18, 2026
- Product Code
- MGZ
- 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 |
|---|---|---|---|
| MGZ | Valvulotome | FDA class 2 | Cardiovascular |
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Other Clearances by LimFlow, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251376 | LimFlow ARC | May 31, 2025 | 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 |