Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8023054

FEI Number

3004216185

Entity Name

BALT EXTRUSION

City/State/Country

MONTMORENCY Val-d'Oise, FR

Establishment Address

10 RUE DE LA CROIX VIGNERON, MONTMORENCY Val-d'Oise 95160, FR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

BALT EXTRUSION (Owner Number: 8023054)

Owner / Operator Contact Address

10 RUE CROIX VIGNERON, MONTMORENCY, FR-95 95160, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Magic HYBRID Guidewire Eclipse 2L Occlusion Balloon Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2008-01-08
MOF	Guide, Wire, Catheter, Neurovasculature	Cardiovascular	Class 2	870.1330	2019-06-30
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2019-06-30
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2020-01-07
MJN	Catheter, Intravascular Occluding, Temporary	Cardiovascular	Class 2	870.4450	2020-01-07

Official Correspondent

David Vu

US Agent Details

David Vu Business: Balt USA, LLC Email: David.Vu@baltgroup.com Phone: (949) 7881443

Related Public Records

Same Entity

BALT EXTRUSION

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
K150445	Asahi Intecc Co., Ltd.	ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)	2015-06-30
K082922	Lake Region Mfg., Inc.	FREEWAY AND RAILRUNNER GUIDEWIRES	2008-12-09
K890207	E-Z-Em, Inc.	INTERVENTIONAL PRODUCTS - GUIDE WIRES	1989-05-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0031-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8023054. Last updated year: 2026. Please use registration number 8023054 when referencing this establishment in official correspondence.