Skip to content
FDA.report
Public FDA data
NDC
RxNorm
DailyMed
Applications
GUDID
GMDN
PMA
PMN
MAUDE
Recalls
Search FDA.report
Search
Home
Company-Registration
1446233164
Device Listing 1446233164
Listing Summary
#
Listing key
1446233164
Premarket submission
K241888
Device
Single-use Balloon Dilatation Catheter
Applicant
Leo Medical Co., Ltd.
Product code
FGE
Decision date
2024-12-20
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
336931
3011347300
3011347300
LEO MEDICAL CO., LTD.
1
N
2026-01-01
No.10 Building, 23 Middle Huashan Road, Xinbei District, 213022, Jiangsu Province, PEOPLE'S REPUBLIC OF CHINA Changzhou Jiangsu CN 213022