BALT USA, LLC

Matched from indexed company URL: BALT USA LLC

FDA Registration(s)#

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

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00840303713128Carrier XL Delivery Catheter - The Carrier XL Delivery Catheter is a single lumen, variable stiffness, composite catheter. The design facilitates the advancement of the catheter and is intended to assist the delivery of interventional devices in the peripheral and neurovasculature. The outer surface of the Carrier XL Delivery Catheter is coated with a hydrophilic coating to increase lubricity. The proximal end of the Carrier XL Delivery Catheter incorporates a luer fitting for the attachment of accessories. Two radiopaque markers at the distal end help to facilitate fluoroscopic visualization. A Steam Shaping Mandrel and Peel-away Introducer Tube are included within the tray. The Carrier XL Delivery Catheter is provided sterile, non-pyrogenic, and is intended for single use only.1-949-788-1443customerservice@balt-usa.com
00840303713135Carrier XL Delivery Catheter - The Carrier XL Delivery Catheter is a single lumen, variable stiffness, composite catheter. The design facilitates the advancement of the catheter and is intended to assist the delivery of interventional devices in the peripheral and neurovasculature. The outer surface of the Carrier XL Delivery Catheter is coated with a hydrophilic coating to increase lubricity. The proximal end of the Carrier XL Delivery Catheter incorporates a luer fitting for the attachment of accessories. Two radiopaque markers at the distal end help to facilitate fluoroscopic visualization. A Steam Shaping Mandrel and Peel-away Introducer Tube are included within the tray. The Carrier XL Delivery Catheter is provided sterile, non-pyrogenic, and is intended for single use only.1-949-788-1443customerservice@balt-usa.com
00840303713470Carrier XL Delivery Catheter - The Carrier XL Delivery Catheter is a single lumen, variable stiffness, composite catheter. The design facilitates the advancement of the catheter and is intended to assist the delivery of interventional devices in the peripheral and neurovasculature. The outer surface of the Carrier XL Delivery Catheter is coated with a hydrophilic coating to increase lubricity. The proximal end of the Carrier XL Delivery Catheter incorporates a luer fitting for the attachment of accessories. Two radiopaque markers at the distal end help to facilitate fluoroscopic visualization. A Steam Shaping Mandrel and Peel-away Introducer Tube are included within the tray. The Carrier XL Delivery Catheter is provided sterile, non-pyrogenic, and is intended for single use only.1-949-788-1443customerservice@balt-usa.com
00840303713531Stellar Guide Catheter - Stellar Guide Catheter is a single-lumen, flexible, variable stiffness composite catheter. The distal tip of the catheter shaft includes a marker band while the proximal end of the catheter has a luer fitting to allow attachment of accessories and infusion of liquids through the system. The Stellar Guide Catheter distal shaft has an external hydrophilic coating which provides a lubricious surface during use. The Stellar Guide Catheter is visible under fluoroscopy. The Stellar Guide Catheter is offered in various sizes to accommodate physician preferences and anatomical variations. A peelable split introducer sheath is provided in the package to provide support and facilitate the introduction of the distal tip of the Stellar Guide Catheter into an appropriate vascular sheath. The catheter and introducer sheath are provided sterile, non-pyrogenic, and are intended for single use use only.1-949-788-1443customerservice@balt-usa.com
00840303713548Stellar Guide Catheter - Stellar Guide Catheter is a single-lumen, flexible, variable stiffness composite catheter. The distal tip of the catheter shaft includes a marker band while the proximal end of the catheter has a luer fitting to allow attachment of accessories and infusion of liquids through the system. The Stellar Guide Catheter distal shaft has an external hydrophilic coating which provides a lubricious surface during use. The Stellar Guide Catheter is visible under fluoroscopy. The Stellar Guide Catheter is offered in various sizes to accommodate physician preferences and anatomical variations. A peelable split introducer sheath is provided in the package to provide support and facilitate the introduction of the distal tip of the Stellar Guide Catheter into an appropriate vascular sheath. The catheter and introducer sheath are provided sterile, non-pyrogenic, and are intended for single use use only.1-949-788-1443customerservice@balt-usa.com
00840303713593Stellar Guide Catheter - The Stellar Guide Catheter is a single-lumen, flexible, variable stiffness composite catheter. The distal tip of the catheter shaft includes a marker band while the proximal end of the catheter has a luer fitting to allow attachment of accessories and infusion of liquids through the system. The Stellar Guide Catheter distal shaft has an external hydrophilic coating which provides a lubricious surface during use. The Stellar Guide Catheter is visible under fluoroscopy. The Stellar Guide Catheter dimensions are included on the individual device label. The Stellar Guide Catheter is offered in various sizes to accommodate physician preferences and anatomical variations.1-949-788-1443customerservice@balt-usa.com
00840303713609Stellar Guide Catheter - The Stellar Guide Catheter is a single-lumen, flexible, variable stiffness composite catheter. The distal tip of the catheter shaft includes a marker band while the proximal end of the catheter has a luer fitting to allow attachment of accessories and infusion of liquids through the system. The Stellar Guide Catheter distal shaft has an external hydrophilic coating which provides a lubricious surface during use. The Stellar Guide Catheter is visible under fluoroscopy. The Stellar Guide Catheter dimensions are included on the individual device label. The Stellar Guide Catheter is offered in various sizes to accommodate physician preferences and anatomical variations.1-949-788-1443customerservice@balt-usa.com
00840303713616Stellar Guide Catheter - The Stellar Guide Catheter is a single-lumen, flexible, variable stiffness composite catheter. The distal tip of the catheter shaft includes a marker band while the proximal end of the catheter has a luer fitting to allow attachment of accessories and infusion of liquids through the system. The Stellar Guide Catheter distal shaft has an external hydrophilic coating which provides a lubricious surface during use. The Stellar Guide Catheter is visible under fluoroscopy. The Stellar Guide Catheter dimensions are included on the individual device label. The Stellar Guide Catheter is offered in various sizes to accommodate physician preferences and anatomical variations.1-949-788-1443customerservice@balt-usa.com

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#

GUDID#

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