FDA Registration
Active
🇯🇵 Japan
FMD Peripheral Guidewire F-14 Tapered3
Reg #: 3013023134
·
FEI: 3013023134
·
Expires 2025
Products
1
Proprietary Names
10
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- FMD. Co., Ltd.
- Registration Number
- 3013023134
- FEI Number
- 3013023134
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1-166 Shimoobari Nakashima
- City
- Komaki Aichi
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K212268
Owner / Operator
- Firm Name
- FMD Co., Ltd.
- Operator Number
- 10052039
- Address
- Sasazuka Daiichi Bldg. 8F, 1-57-7 Sasazuka, Shibuya-ku
- City
- Tokyo
- State
- JP-13
- Postal Code
- 151-0073
- Country
- JP
- Correspondent
- Mayumi Ito
US Agent
- Business Name
- Far West Consulting, LLC
- Contact Name
- Max Bynum
- Address
- 4768 Woodview Dr
- City
- Santa Rosa
- State
- CA
- ZIP
- 95405
- Country
- US
- [email protected]
- Phone
- 707 2900082
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2022-11-21 |
Proprietary Names
FMD Peripheral Guidewire F-14 Tapered3
FMD Peripheral Guidewire F-14 Flex
FMD Peripheral Guidewire F-14 Light
FMD Peripheral Guidewire F-14 Tapered30
FMD Peripheral Guidewire F-18 Hard15
FMD Peripheral Guidewire F-18 Flex
FMD Peripheral Guidewire F-18 Floppy
FMD Peripheral Guidewire F-14 Gentle
FMD Peripheral Guidewire F-14 Tapered15
FMD Peripheral Guidewire F-14 EXT
Establishment Types
Manufacture Medical Device