Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013666336

FEI Number

3013666336

Entity Name

Heraeus Medical Components, SRL

City/State/Country

Guadalupe Cartago, CR

Establishment Address

Parque Industrial Zona Franca La Lima, Building 29, Guadalupe Cartago 30106, CR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Heraeus Medical Components, LLC (Owner Number: 9045241)

Owner / Operator Contact Address

5030 Centerville Road, Saint Paul, MN 55127, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Vascupuncture Guidewires Spring Coil Guidewire FlexCath Cross Transseptal Solution Vascupuncture Guidewires FlexCath Cross Transseptal Solution FlexCath Cross Transseptal Solution Vascupuncture Guidewires

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-10-16
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2015-02-24
MMX	Device, Percutaneous Retrieval	Cardiovascular	Class 2	870.5150	2016-03-31
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2025-05-13
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2025-05-13
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-10-16
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2015-03-26
DXF	Catheter, Septostomy	Cardiovascular	Class 2	870.5175	2025-12-03
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2022-09-07
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2025-05-13
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2025-05-13
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2025-05-13
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2025-05-13
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-10-16

Official Correspondent

Timothy Desaulniers

US Agent Details

Timothy Desaulniers Business: Heraeus Medical Components, LLC Email: tim.desaulniers@heraeus.com Phone: (612) 3252003

Related Public Records

Same Entity

Heraeus Medical Components, LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3005029049	Heraeus Medical Components Caribe, Inc.	DORADO, PR, US
3008988055	HERAEUS MEDICAL COMPONENTS, LLC	Saint Paul, MN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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
K992169	Advanced Cardiovascular Systems, Inc.	ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE	1999-10-28
K012534	Advanced Cardiovascular Systems, Inc.	HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING	2002-01-24

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-0783-2020	Abbott Medical	2	Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020	Abbott Medical	2	Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013666336. Last updated year: 2026. Please use registration number 3013666336 when referencing this establishment in official correspondence.