Balt USA, LLC

FDA Filings

This page includes the latest FDA filings for Balt USA, LLC. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
Balt USA, LLC
Optima Coil System2020-02-01
Balt USA, LLC
Eclipse 2L2019-04-30
Balt USA LLC
Ballast 088 Long Sheath2019-03-21
Balt USA, LLC
HYBRID Guidewire2018-10-04

Latest Premarket Applications

PMAManufacturerDevice NameDate

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
ECLIPSE 2L
BALT USA LLC2019-07-23
ECLIPSE 2L
BALT USA LLC2019-07-23
ECLIPSE 2L
BALT USA LLC2019-07-23
ECLIPSE 2L
BALT USA LLC2019-07-23
ECLIPSE 2L
BALT USA LLC2019-07-23
ECLIPSE 2L
BALT USA LLC2019-07-23
Ballast 088 Long Sheath
BALT USA LLC2019-07-23
Ballast 088 Long Sheath
BALT USA LLC2019-07-23
Ballast 088 Long Sheath
BALT USA LLC2019-07-23
Ballast 088 Long Sheath
BALT USA LLC2019-07-23
Magic Infusion Catheter
BALT USA LLC2019-07-09
Magic Infusion Catheter
BALT USA LLC2019-07-09
Magic Infusion Catheter
BALT USA LLC2019-07-09
Magic Infusion Catheter
BALT USA LLC2019-07-09
Magic Infusion Catheter
BALT USA LLC2019-07-09
Magic Infusion Catheter
BALT USA LLC2019-07-09
Magic Infusion Catheter
BALT USA LLC2019-07-09
Magic Infusion Catheter
BALT USA LLC2019-07-09
Magic Infusion Catheter
BALT USA LLC2019-07-09
Barricade Coil System
BALT USA LLC2019-07-09
Barricade Coil System
BALT USA LLC2019-07-09
XCEL Detach
BALT USA LLC2019-02-11
ULTRA Detach
BALT USA LLC2019-02-11
Optima Coil System
BALT USA LLC2019-02-01
Optima Coil System
BALT USA LLC2019-02-01
Optima Coil System
BALT USA LLC2019-02-01
Optima Coil System
BALT USA LLC2019-02-01
Optima Coil System
BALT USA LLC2019-02-01
Optima Coil System
BALT USA LLC2019-02-01
Optima Coil System
BALT USA LLC2019-02-01
Optima Coil System
BALT USA LLC2019-02-01
Optima Coil System
BALT USA LLC2019-02-01
Optima Coil System
BALT USA LLC2019-02-01
Optima Coil System
BALT USA LLC2019-02-01
Optima Coil System
BALT USA LLC2019-02-01

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