CPE1, LLC DBA Greatbatch Medical

FDA Device Registration & Listing · Southwest Ranches, FL, US · Registration 3017168767

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3017168767
FEI Number
3017168767
Entity Name
CPE1, LLC DBA Greatbatch Medical
City/State/Country
Southwest Ranches, FL, US
Establishment Address
19700 Stirling Road, Suite 1, Southwest Ranches, FL 33332, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Integer (Owner Number: 10091663)
Owner / Operator Contact Address
19700 Stirling Road, Suite 1, Southwest Ranches, FL 33332, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

CPE1, LLC DBA Greatbatch Medical CPE1, LLC DBA Greatbatch Medical CPE1, LLC DBA Greatbatch Medical CPE1, LLC DBA Greatbatch Medical CPE1, LLC DBA Greatbatch Medical CPE1, LLC DBA Greatbatch Medical CPE1, LLC DBA Greatbatch Medical CPE1, LLC DBA Greatbatch Medical CPE1, LLC DBA Greatbatch Medical CPE1, LLC DBA Greatbatch Medical

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2024-10-22
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2024-10-22
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2024-10-22
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2025-08-29
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2024-10-22
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2024-10-22
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2024-10-22
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2024-10-22
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2024-10-22
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2024-10-22
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2024-10-22
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2024-10-22
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2024-10-22
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2025-08-29
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2025-08-29

Official Correspondent

Mariela Martinez

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Integer
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
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017168767. Last updated year: 2026. Please use registration number 3017168767 when referencing this establishment in official correspondence.
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