I.V. Administration Set, I.V. Extension Set
FDA 510(k) clearance K223645 · decided 2023-05-18
Clearance details
- K-number
- K223645
- Device name
- I.V. Administration Set, I.V. Extension Set
- Applicant
- Bq Plus Medical Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-12-06
- Decision date
- 2023-05-18
- Days to decision
- 163 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Shanghai, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.