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 00840303712817 BALT USA LLC	Ballast 088 Long Sheath N/A	2024-08-22
GUDID 00840303712800 BALT USA LLC	Ballast 088 Long Sheath N/A	2024-08-22
GUDID 00840303712794 BALT USA LLC	Ballast 088 Long Sheath N/A	2024-08-22
GUDID 00840303712787 BALT USA LLC	Ballast 088 Long Sheath N/A	2024-08-22
GUDID 00840303712770 BALT USA LLC	Revere Hybrid Access Catheter N/A	2024-08-22
GUDID 00840303712763 BALT USA LLC	Revere Hybrid Access Catheter N/A	2024-08-22
GUDID 00840303712756 BALT USA LLC	Revere Hybrid Access Catheter N/A	2024-08-22
GUDID 00840303712749 BALT USA LLC	Revere Hybrid Access Catheter N/A	2024-08-22
GUDID 00840303712732 BALT USA LLC	Revere Hybrid Access Catheter N/A	2024-08-22
GUDID 00840303712725 BALT USA LLC	Revere Hybrid Access Catheter N/A	2024-08-22
GUDID 00840303712718 BALT USA LLC	Revere Hybrid Access Catheter N/A	2024-08-22
GUDID 00840303712701 BALT USA LLC	Revere Hybrid Access Catheter N/A	2024-08-22
GUDID 00840303712695 BALT USA LLC	Revere Hybrid Access Catheter N/A	2024-08-22
GUDID 00840303712688 BALT USA LLC	Ballast 088 Long Sheath N/A	2024-08-22
GUDID 00840303712671 BALT USA LLC	Ballast 088 Long Sheath N/A	2024-08-22
GUDID 00840303709497 BALT USA LLC	Ballast 088 Long Sheath N/A	2024-08-22
GUDID 00840303709480 BALT USA LLC	Ballast 088 Long Sheath N/A	2024-08-22
GUDID 00840303709473 BALT USA LLC	Ballast 088 Long Sheath N/A	2024-08-22
GUDID 00840303709466 BALT USA LLC	Ballast 088 Long Sheath N/A	2024-08-22
GUDID 00840303709671 BALT USA LLC	Stellar Guide Catheter N/A	2024-07-31
GUDID 00840303709664 BALT USA LLC	Stellar Guide Catheter N/A	2024-07-31
GUDID 00840303709657 BALT USA LLC	Stellar Guide Catheter N/A	2024-07-31
GUDID 00840303709640 BALT USA LLC	Stellar Guide Catheter N/A	2024-07-31
GUDID 00840303709633 BALT USA LLC	Stellar Guide Catheter	2024-07-31
GUDID 00840303709626 BALT USA LLC	Stellar Guide Catheter N/A	2024-07-31
GUDID 00840303709619 BALT USA LLC	Stellar Guide Catheter N/A	2024-07-31
GUDID 00840303709411 BALT USA LLC	Raptor Aspiration Catheter N/A	2024-07-31
GUDID 00840303709404 BALT USA LLC	Raptor Aspiration Catheter	2024-07-31
GUDID 00840303709398 BALT USA LLC	Raptor Aspiration Catheter N/A	2024-07-31
GUDID 00840303709381 BALT USA LLC	Raptor Aspiration Catheter N/A	2024-07-31
GUDID 00810068568059 BALT USA LLC	Carrier™ Delivery Catheter N/A	2023-11-15
GUDID 00810068561982 BALT USA LLC	Carrier™ Delivery Catheter N/A	2023-11-15
GUDID 00810068561944 BALT USA LLC	Carrier™ Delivery Catheter N/A	2023-11-15
GUDID 00818053029639 BALT USA LLC	ULTRA Detach	2023-05-03
GUDID 00810068568042 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068568028 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567878 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567861 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567854 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567847 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567830 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567823 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567816 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567809 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567793 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567786 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567779 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567762 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567755 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567748 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567731 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567724 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567717 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567700 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567694 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567687 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567670 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567663 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567656 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567649 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567632 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567625 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567618 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567601 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567595 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567588 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567571 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567564 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567557 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567540 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567519 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567502 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567496 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567489 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567472 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567465 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567458 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567441 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567434 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567427 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567410 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567403 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567397 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567380 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567373 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567366 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567359 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567342 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567335 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567328 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567311 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00810068567304 BALT USA LLC	Prestige Coil System	2022-08-02
GUDID 00818053027185 BALT USA LLC	Prestige Coil System	2021-10-13
GUDID 00818053027178 BALT USA LLC	Prestige Coil System	2021-10-13
GUDID 00818053027161 BALT USA LLC	Prestige Coil System	2021-10-13
GUDID 00818053027154 BALT USA LLC	Prestige Coil System	2021-10-13
GUDID 00818053027147 BALT USA LLC	Prestige Coil System	2021-10-13
GUDID 00818053027130 BALT USA LLC	Prestige Coil System	2021-10-13
GUDID 00818053027123 BALT USA LLC	Prestige Coil System	2021-10-13
GUDID 00818053027116 BALT USA LLC	Prestige Coil System	2021-10-13
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