Optima Coil System (Optima Packing Coil System)
Balt USA, LLC
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3014162263 | 3014162263 | BALT USA, LLC | 1 | N | 2026-01-01 | 29 Parker Irvine CA US 92618 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00840303713128 | Carrier 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. | 1-949-788-1443 | customerservice@balt-usa.com |
| 00840303713135 | Carrier 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. | 1-949-788-1443 | customerservice@balt-usa.com |
| 00840303713470 | Carrier 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. | 1-949-788-1443 | customerservice@balt-usa.com |
| 00840303713531 | Stellar 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. | 1-949-788-1443 | customerservice@balt-usa.com |
| 00840303713548 | Stellar 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. | 1-949-788-1443 | customerservice@balt-usa.com |
| 00840303713593 | Stellar 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. | 1-949-788-1443 | customerservice@balt-usa.com |
| 00840303713609 | Stellar 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. | 1-949-788-1443 | customerservice@balt-usa.com |
| 00840303713616 | Stellar 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. | 1-949-788-1443 | customerservice@balt-usa.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 216197 | 2018930622 | P250009 | SQUID Liquid Embolic Agent (LEA) | SGU | 2026-01-30 |
| 216197 | 1022652207 | K260199 | SLIM Microcatheter | QJP | 2026-07-13 |
| 216197 | 1689946564 | K254223 | Next Generation 088 Catheter | QJP | 2026-04-16 |
| 216197 | 1062812917 | K254221 | Optima Coil System (OptiOne Coil System) | HCG | 2026-01-27 |
| 216197 | 1271778258 | K252700 | Optima Coil System (Optima Packing Coil System) | HCG | 2025-09-26 |
| 216197 | 1712087144 | K252569 | Carrier XL Delivery Catheter | QJP | 2025-10-22 |
| 216197 | 1577251605 | K251383 | Prestige Coil System (Prestige Packing Line Extension) | KRD | 2025-05-30 |
| 216197 | 1403698946 | K243948 | Raptor Aspiration Catheter; Balt Aspiration Tubing Set | NRY | 2025-06-03 |
| 216197 | 1365608483 | K242582 | Optima Coil System (OptiBlock Line Extension) | HCG | 2024-09-27 |
| 216197 | 2034973077 | K242376 | Next Generation Access Platform | QJP | 2024-12-30 |
| 216197 | 1308494738 | K234083 | Next Generation Aspiration Catheter; Balt Aspiration Tubing Set | NRY | 2024-07-02 |
| 216197 | 1538139412 | K234074 | Next Generation Access Catheter | QJP | 2024-07-02 |
| 216197 | 1789028884 | K230609 | NG Delivery Catheter | QJP | 2023-09-13 |
| 216197 | 1736614425 | K223386 | Optima Coil System | HCG | 2022-12-06 |
| 216197 | 1280004328 | K220699 | Prestige Coil System | KRD | 2022-04-08 |
| 216197 | 1520239185 | K213435 | MAGIC Flow-Dependent Microcatheter | KRA | 2022-07-19 |
| 216197 | 1314405223 | K200030 | Optima Coil System | HCG | 2020-02-01 |
| 216197 | 1261677349 | K183045 | Eclipse 2L | MJN | 2019-04-30 |
| 216197 | 1902861340 | K182918 | Ballast 088 Long Sheath | DQY | 2019-03-21 |
| 216197 | 1967583113 | K182337 | HYBRID Guidewire | MOF | 2018-10-04 |
| 216197 | 1729398654 | K172390 | Optima Coil System | HCG | 2018-02-18 |
| 216197 | 1623676155 | K123338 | BARRICADE EMBOLIZATION COIL SYSTEM | HCG | 2013-03-28 |
| 216197 | 2007002642 | K023351 | MAGIC INFUSION CATHETER | KRA | 2003-02-20 |
Balt USA, LLC
Balt USA, LLC
Balt USA, LLC
Balt USA, LLC
Balt USA, LLC
Balt USA, LLC
Balt USA, LLC
Balt USA, LLC
Balt USA, LLC
Balt USA, LLC
Balt USA, LLC
Balt USA, LLC
Balt USA, LLC
Balt USA LLC
Balt USA, LLC
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