Surflo Midela MCS2010D00F
by Terumo Medical Products (Hangzhou) Co., Ltd.
Surflo Midela MCS2010D00F is a Class II device made by Terumo Medical Products (Hangzhou) Co., Ltd., cleared under FDA 510(k) K252402 on 18 Dec 2025 and listed in FDA GUDID since 1 Apr 2026 (UDI-DI 36927675517280), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number36927675517280 | Date1 Apr 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK252402 | Date18 Dec 2025 | StatusActive |
Official records
- AccessGUDID record 36927675517280
- FDA 510(k) database K252402
Across registries
- FDA 510(k) K252402 decided 18 Dec 2025 Active
- FDA GUDID UDI-DI 36927675517280 listed 1 Apr 2026 Listed
Timeline
- Cleared FDA 510(k) K252402
- Listed FDA GUDID 36927675517280
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Surflo Midela
- Generic name
- Peripheral vascular intervention infusion catheter
- Model / Ref / Catalog
- MCS2010D00F
- Primary DI / UDI-DI
- 36927675517280
- 510(k) Number
- FDA product code
- FOZ, PND
- GMDN term
- Peripheral vascular intervention infusion catheter
- Device class
- Class II
- Regulation number
- 880.5200
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Size
- Length — 100 MillimeterCatheter Gauge — 1.0 French
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