Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007882731

FEI Number

3007882731

Entity Name

Greatbatch Medical, S. de R.L. de C.V.

City/State/Country

Tijuana Baja California, MX

Establishment Address

Boulevard Hector Teran Teran #20120, Ciudad Industrial, Tijuana Baja California 22444, MX

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

GREATBATCH MEDICAL (Owner Number: 9035261)

Owner / Operator Contact Address

2300 Berkshire Lane N, --, Plymouth, MN 55441, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Tissue Sparing Solutions Low Profile Reamer 66mm

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2009-07-01
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2009-07-01
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2014-12-10
HTO	Reamer	Orthopedic	Class 1	888.4540	1997-01-16
LGW	Stimulator, Spinal-Cord, Totally Implanted For Pain Relief	Unknown	Class 3	N/A	2016-12-02
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)	Neurology	Class 2	882.5880	2013-01-31
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2016-11-21
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2011-03-13
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2011-03-13
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2023-06-22
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2017-02-09

Official Correspondent

No official correspondent registered.

US Agent Details

Maria Mundaden Email: maria.mundaden@integer.net Phone: (763) 9518200

Related Public Records

Same Entity

GREATBATCH MEDICAL

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3011823740	Greatbatch Medical S. de R.L. de C.V.	Tijuana Baja California, MX
3010326622	Centro de Construccion de Cardioestimuladores del Uruguay S.A.	Montevideo, UY
2183787	Greatbatch Medical	Minneapolis, MN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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
K132420	Reflow Medical	WINGMAN EXTENDABLE TIP SUPPORT CATHETER	2013-09-19
K082339	Endocross, Ltd.	ENABLER-P SUPPORT CATHETER	2008-11-20
K210009	CenterPoint Systems, LLC	Guiding Catheter	2021-11-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0010-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter

Similar Registrations

Registration Number	Establishment Name	Location
3039062605	CORVITEX CORPORATION	Raleigh, NC, US
3031768596	PIRAEUS MEDICAL, INC.	Maple Grove, MN, US
3013134719	HEXACATH	Rueil Malmaison Ile-de-France, FR
3011142981	Rontis Hellas S.A.	Larisa Thessalia, GR
3010370269	STRAIT ACCESS TECHNOLOGIES HOLDINGS (PTY) LTD	Cape Town Western Cape, ZA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007882731. Last updated year: 2026. Please use registration number 3007882731 when referencing this establishment in official correspondence.