FDA.reportPublic FDA data

BALT USA, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30141622633014162263BALT USA, LLC1N2026-01-0129 Parker Irvine CA US 92618

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2161972018930622P250009SQUID Liquid Embolic Agent (LEA)SGU2026-01-30
2161971022652207K260199SLIM MicrocatheterQJP2026-07-13
2161971689946564K254223Next Generation 088 CatheterQJP2026-04-16
2161971062812917K254221Optima Coil System (OptiOne Coil System)HCG2026-01-27
2161971271778258K252700Optima Coil System (Optima Packing Coil System)HCG2025-09-26
2161971712087144K252569Carrier XL Delivery CatheterQJP2025-10-22
2161971577251605K251383Prestige Coil System (Prestige Packing Line Extension)KRD2025-05-30
2161971403698946K243948Raptor Aspiration Catheter; Balt Aspiration Tubing SetNRY2025-06-03
2161971365608483K242582Optima Coil System (OptiBlock Line Extension)HCG2024-09-27
2161972034973077K242376Next Generation Access PlatformQJP2024-12-30
2161971308494738K234083Next Generation Aspiration Catheter; Balt Aspiration Tubing SetNRY2024-07-02
2161971538139412K234074Next Generation Access CatheterQJP2024-07-02
2161971789028884K230609NG Delivery CatheterQJP2023-09-13
2161971736614425K223386Optima Coil SystemHCG2022-12-06
2161971280004328K220699Prestige Coil SystemKRD2022-04-08
2161971520239185K213435MAGIC Flow-Dependent MicrocatheterKRA2022-07-19
2161971314405223K200030Optima Coil SystemHCG2020-02-01
2161971261677349K183045Eclipse 2LMJN2019-04-30
2161971902861340K182918Ballast 088 Long SheathDQY2019-03-21
2161971967583113K182337HYBRID GuidewireMOF2018-10-04
2161971729398654K172390Optima Coil SystemHCG2018-02-18
2161971623676155K123338BARRICADE EMBOLIZATION COIL SYSTEMHCG2013-03-28
2161972007002642K023351MAGIC INFUSION CATHETERKRA2003-02-20

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HCG72026-01-27
QJP62026-07-13
NRY22025-06-03
KRD22025-05-30
KRA22022-07-19
MJN12019-04-30
DQY12019-03-21
MOF12018-10-04

PMN#