510(k) K192681
K192681 is an FDA 510(k) premarket notification submitted by Jiangsu Kangbao Medical Equipment Co., Ltd. for the device "Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle holder type), Safety blood collection needle (Scalp vein set type), Safety blood collection needle (Needle holder type)". The FDA issued a decision of Substantially Equivalent on July 28, 2020. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Jiangsu Kangbao Medical Equipment Co., Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 28, 2020
- Date Received
- September 26, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, Administration, Intravascular
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type