FDA.reportPublic FDA data

BROSMED MEDICAL CO.,LTD

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30103912653010391265BROSMED MEDICAL CO.,LTD1N2026-01-0115th Building, SMEs Venture Park SongShan Lake Hi-Tech Industrial Development Zon Dongguan Guangdong CN 523808

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1608761451329255K243704Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation CatheterLIT2025-02-27
1608761608108007K241478Tri-Wedge PTA Scoring Balloon Dilatation CatheterPNO2024-10-22
1608761916744547K230705POT PTCA Balloon Dilatation CatheterLOX2023-04-11
1608762042352975K212215Tiche PTA Balloon Dilatation CatheterLIT2022-07-19
1608761664278428K203390Artimes pro Balloon Dilatation CatheterLOX2021-04-14
1608761854808090K160941Castor, Achilles and Hermes NC PTA Balloon Dilatation CatheterLIT2016-12-13
1608761726042472K160256Polux , Minerva and Atropos PTA Balloon Dilatation CatheterLIT2016-07-29
1608762023425917K153742Apollo Balloon Dilatation CatheterLOX2016-08-08
1608761389069513K141025ARTIMES BALLOON DILATATION CATHETERLOX2014-09-12
1608761846225743K133852APOLLO BALLOON DILATATION CATHETERLOX2014-09-19
1608761562038090
1608761899321980

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LOX52023-04-11
LIT42025-02-27
PNO12024-10-22