Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder
FDA 510(k) clearance K232881 · decided 2023-12-22
Clearance details
- K-number
- K232881
- Device name
- Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder
- Applicant
- Jiangsu Kangbao Medical Equipment Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-09-18
- Decision date
- 2023-12-22
- Days to decision
- 95 days
- Clearance type
- Traditional
- Product code
- JKA
- Device class
- 2
- Regulation number
- 862.1675
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Yangzhou, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.