510(k) K192681

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) by Jiangsu Kangbao Medical Equipment Co., Ltd. — Product Code FPA

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