FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT
K Number: K212268
·
Decision May 27, 2022
Classifications
1
FEI Numbers
257
Registration Numbers
258
Same Product Code
763
Applicant Total
3
Review Days
311
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Basic Information
- Device Name
- FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT
- K Number
- K212268
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- FMD Co., Ltd.
- Date Received
- July 20, 2021
- Decision Date
- May 27, 2022
- Product Code
- DQX
- 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 |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | FDA class 2 | Cardiovascular |
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Other Clearances by FMD Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K260544 | FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40 | Mar 20, 2026 | Substantially Equivalent |
| K240460 | FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259) | Jun 13, 2024 | Substantially Equivalent |