Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014162263

FEI Number

3014162263

Entity Name

BALT USA, LLC

City/State/Country

Irvine, CA, US

Establishment Address

29 Parker, Irvine, CA 92618, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Balt USA, LLC (Owner Number: 10041614)

Owner / Operator Contact Address

29 Parker, Irvine, CA 92618, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K213435

PMA Number

N/A

All Registered Proprietary Names

Magic Infusion Catheter Prestige Coil System (Prestige Packing Line Extension) Optima Coil System XCEL Detachment Controller Stellar Guide Catheter Carrier XL Delivery Catheter Barricade Coil System Optima Coil System Ultra Detachment Controller XCEL Detachment Controller Allure Coil System Detachment Controller Allure Coil System Prestige Coil System Raptor Aspiration Catheter Raptor Aspiration Catheter; Balt Aspiration Tubing Set Optima Coil System (OptiOne Coil System) Prestige Coil System Prestige Plus Coil System MAGIC Flow-Dependent Microcatheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2017-04-03
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2025-06-04
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2018-02-20
SGU	Neurovascular Liquid Embolic Agent	Unknown	Class 3	N/A	2026-02-12
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2024-07-16
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2024-07-16
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2025-12-18
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2025-12-18
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2017-06-13
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2020-02-26
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2020-02-26
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2024-07-16
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2025-06-04
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2026-01-28
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2026-01-28
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2022-06-10
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2023-09-01
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2023-09-01

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Balt USA, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K792141	Pharmaseal Div., Baxter Healthcare Corp.	CONTINUOUS FLUSH DEVICE	1979-12-05
K924661	Baxter Healthcare Corp	SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER	1993-04-08
K951256	Target Therapeutics	DETACHABLE PLATINUM COIL (GUGLIELMI DETACHABLE COIL, GDC)	1995-09-08
K043580	Chestnut Medical Technologies, Inc.	ALLIGATOR RETRIEVAL DEVICE (ARD)	2005-03-24
K982883	Medtronics Interventional Vascular	MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER	1998-09-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0021-2025	Stryker Neurovascular	2	The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating on the distal 100cm to reduce friction during use. The radiopaque shaft and distal marker(s) facilitate fluoroscopic visualization. A rotating hemostatic valve with side-arm adapter is provided with each microcatheter.
Z-0001-2010	Penumbra Inc.	2	Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014	Cordis Corporation	2	Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Z-0009-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Z-0010-04	Bard Peripheral Vascular	2	Conquest Balloon Dilation Catheters Model/Catalog Number CQ 75124

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3026567963	ENDOVASCULAR ENGINEERING, INC.	Menlo Park, CA, US
3021067373	VVT MED Ltd	Kfar Saba Central, IL
3019525998	VASCUPATENT MEDICAL (SHENZHEN) CO., LTD	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014162263. Last updated year: 2026. Please use registration number 3014162263 when referencing this establishment in official correspondence.