Balt Usa L L C

FDA Filings

This page includes the latest FDA filings for Balt Usa L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Balt Usa L L C holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• Moises Colin

FDA Registration(s)

• Registration Number: 3014162263
• FEI Number: 3014162263
• Name: BALT USA, LLC
• Owner & Operator: Balt USA, LLC
• Contact Address: 29 Parker ; Irvine CA 92618 US
• Official Correspondent:
  • Moises Colin
  • x-949-7881443-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 29 Parker ; Irvine, CA 92618 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 00840303709374 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303709367 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303709350 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303709343 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303709336 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303709329 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303709312 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303709305 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303709299 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303709282 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303709275 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303709268 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303709251 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303709244 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303709237 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303709220 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303709213 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303709206 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303709190 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303709183 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303709176 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303709169 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303709152 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303709145 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303709138 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303709121 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303709114 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303709107 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303709091 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303709084 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303709077 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303709060 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303709053 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303709046 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303709039 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303709022 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303709015 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303709008 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303708995 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303708988 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303708971 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303708964 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303708957 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303708940 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303708933 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303708926 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303708919 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303708902 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303708896 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303708889 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303708872 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303708865 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303708858 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303708841 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303708834 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303708827 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303708810 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303708803 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303708797 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303708780 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303708773 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303708766 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303708759 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303708742 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303708735 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303708728 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303708711 BALT USA LLC	Prestige Coil System N/A	2024-12-02
GUDID 00840303708483 BALT USA LLC	Prestige Coil System N/A	2024-11-29
GUDID 00840303708476 BALT USA LLC	Prestige Coil System N/A	2024-11-29
GUDID 00840303708469 BALT USA LLC	Prestige Coil System N/A	2024-11-29
GUDID 00840303708452 BALT USA LLC	Prestige Coil System N/A	2024-11-29
GUDID 00840303708445 BALT USA LLC	Prestige Coil System N/A	2024-11-29
GUDID 00840303708438 BALT USA LLC	Prestige Coil System N/A	2024-11-29
GUDID 00840303708421 BALT USA LLC	Prestige Coil System N/A	2024-11-29
GUDID 00840303708414 BALT USA LLC	Prestige Coil System N/A	2024-11-29
GUDID 00840303708407 BALT USA LLC	Prestige Coil System N/A	2024-11-29
GUDID 00840303708391 BALT USA LLC	Prestige Coil System N/A	2024-11-29
GUDID 00840303708384 BALT USA LLC	Prestige Coil System N/A	2024-11-29
GUDID 00840303708377 BALT USA LLC	Prestige Coil System N/A	2024-11-29
GUDID 00840303708360 BALT USA LLC	Prestige Coil System N/A	2024-11-29
GUDID 00840303708353 BALT USA LLC	Prestige Coil System N/A	2024-11-29
GUDID 00840303708346 BALT USA LLC	Prestige Coil System N/A	2024-11-29
GUDID 00840303708339 BALT USA LLC	Prestige Coil System N/A	2024-11-29
GUDID 00840303708322 BALT USA LLC	Prestige Coil System N/A	2024-11-29
GUDID 00840303708315 BALT USA LLC	Prestige Coil System N/A	2024-11-29
GUDID 00840303708308 BALT USA LLC	Prestige Coil System N/A	2024-11-29
GUDID 00840303708292 BALT USA LLC	Prestige Coil System N/A	2024-11-29
GUDID 00840303708285 BALT USA LLC	Prestige Coil System N/A	2024-11-29
GUDID 00840303708278 BALT USA LLC	Prestige Coil System	2024-11-29
GUDID 00840303708261 BALT USA LLC	Prestige Coil System N/A	2024-11-29
GUDID 00840303708254 BALT USA LLC	Prestige Coil System N/A	2024-11-29
GUDID 00840303708247 BALT USA LLC	Prestige Coil System N/A	2024-11-29
GUDID 00840303708230 BALT USA LLC	Prestige Coil System N/A	2024-11-29
GUDID 00840303708223 BALT USA LLC	Prestige Coil System N/A	2024-11-29
GUDID 00840303708216 BALT USA LLC	Prestige Coil System N/A	2024-11-29
GUDID 00840303708209 BALT USA LLC	Prestige Coil System N/A	2024-11-29
GUDID 00840303708193 BALT USA LLC	Prestige Coil System N/A	2024-11-29
GUDID 00840303708186 BALT USA LLC	Prestige Coil System N/A	2024-11-29
GUDID 00840303708179 BALT USA LLC	Prestige Coil System N/A	2024-11-29
GUDID 00840303708162 BALT USA LLC	Prestige Coil System N/A	2024-11-29
PMN K202366 Balt USA, LLC	MAGIC Infusion Catheter	2021-01-29
PMN K200030 | KRD BALT USA, LLC	Optima Coil System	2020-02-26
PMN K200030 | HCG BALT USA, LLC	Optima Coil System	2020-02-26
PMN K200030 Balt USA, LLC	Optima Coil System	2020-02-01
PMN K183045 | MJN BALT USA, LLC	ECLIPSE 2L	2019-06-12
PMN K183045 | DQY BALT USA, LLC	ECLIPSE 2L	2019-06-12
PMN K182918 | DQY BALT USA, LLC	Ballast 088 Long Sheath	2019-06-12
PMN K183045 Balt USA, LLC	Eclipse 2L	2019-04-30
PMN K182918 Balt USA LLC	Ballast 088 Long Sheath	2019-03-21
PMN K182337 | MOF BALT USA, LLC	HYBRID Guidewire	2018-10-08
PMN K182337 | DQX BALT USA, LLC	HYBRID Guidewire	2018-10-08
PMN K182337 Balt USA, LLC	HYBRID Guidewire	2018-10-04
PMN K172390 | HCG BALT USA, LLC	XCEL Detachment Controller	2018-02-20
PMN K172390 | HCG BALT USA, LLC	Ultra Detachment Controller	2018-02-20
PMN K172390 | HCG BALT USA, LLC	Prestige Coil System	2018-02-20
PMN K172390 | HCG BALT USA, LLC	Optima Coil System	2018-02-20
PMN K123338 | HCG BALT USA, LLC	Barricade Coil System	2017-06-13
PMN K023351 | KRA BALT USA, LLC	Magic Infusion Catheter	2017-04-03