Abbott Medical

FDA Device Registration & Listing · Westford, MA, US · Registration 3009600098

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
3009600098
FEI Number
3009600098
Entity Name
Abbott Medical
City/State/Country
Westford, MA, US
Establishment Address
4 Robbins Rd, Westford, MA 01886, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
ABBOTT LABORATORIES (Owner Number: 1415939)
Owner / Operator Contact Address
100 ABBOTT PARK RD., D-03Q3, AP52-1, Abbott Park, IL 60064, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K180558
PMA Number
N/A

All Registered Proprietary Names

ILUMIEN System and Accessories with Dragonfly OPTIS Imaging Catheter Dragonfly OPTIS Imaging Catheter Kit OPTIS Mobile Next Optis Tableside Controller Next Optis Integrated Next Optis Mobile Next Imaging System Optis Integrated Pre-Install Kit Optis Mobile Next Direct Upgrade Accessory Kit Optis Next Upgrade Kit Ultreon 2 Software Upgrade Kit Ultiri Measurement System OPTIS Mobile System and Accessories ILUMIEN Systems with AptiVue Software Version D.3 ILUMIEN OPTIS Mobile System ILUMIEN OPTIS Mobile System Accessories RadiAnalyzer Xpress Monitor Cable 12900 Series Quantien Measurement System Quantien Mounting Stands and Brackets Quantien Measurement System Monitor Cables C12900 Series RadiAnalyzer Xpress Cable Converter C12784 Quantien Measurement System Adapter C12600 series Quantien Measurement System AUX OUT Cable C12796 Quantien Measurement System C12787 RadiAnalyzer Adapter Cables 12600 series Quantien Measurement System AUX IN Cable C12500-C12510 ILUMIEN OPTIS, OPTIS Integrated, OPTIS Mobile with AptiVue Software version E.5.2 ILUMIEN™ OPTIS™ System AptiVue™ Imaging Software version E.6 OPTIS™ Integrated System OPTIS™ Mobile System PressureWire X

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2017-05-18
NQQ System, Imaging, Optical Coherence Tomography (Oct) Radiology Class 2 892.1560 2017-05-18
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2021-06-08
NQQ System, Imaging, Optical Coherence Tomography (Oct) Radiology Class 2 892.1560 2021-06-08
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2021-06-08
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2013-04-02
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2013-04-02
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2022-06-22
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2022-06-22
NQQ System, Imaging, Optical Coherence Tomography (Oct) Radiology Class 2 892.1560 2017-05-18
NQQ System, Imaging, Optical Coherence Tomography (Oct) Radiology Class 2 892.1560 2020-10-21
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2020-10-21
NQQ System, Imaging, Optical Coherence Tomography (Oct) Radiology Class 2 892.1560 2017-05-18
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2019-12-11
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2019-12-11
NQQ System, Imaging, Optical Coherence Tomography (Oct) Radiology Class 2 892.1560 2019-04-02
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2019-04-02
NQQ System, Imaging, Optical Coherence Tomography (Oct) Radiology Class 2 892.1560 2023-09-26
DXO Transducer, Pressure, Catheter Tip Cardiovascular Class 2 870.2870 2018-06-28
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2018-06-28
DRG Transmitters And Receivers, Physiological Signal, Radiofrequency Cardiovascular Class 2 870.2910 2018-06-28

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ABBOTT LABORATORIES
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3004032053 Abbott S.r.l. Milan Lombardy, IT
3011706799 Abbott Medical Atlanta, GA, US
1628664 ABBOTT LABORATORIES IRVING, TX, US
3023268435 Abbott Automation Solutions GmbH Hamburg, DE
3001883144 St. Jude Medical Brasil Ltda. Belo Horizonte Minas Gerais, BR

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K151126 Colibri Technologies, Inc. Foresight Intracardiac Echocardiography (ICE) System 2015-12-18
K931629 Carapace, Inc. CARAPACE ANGIOGRAPHY TRAYS 1993-12-06
K823758 Access Devices, Inc. CENTRAL VEIN CATHERIZATION KIT 1983-02-23
K192019 ABBOTT MEDICAL Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1 2019-11-08
K230411 ABBOTT MEDICAL Dragonfly OpStar™ Imaging Catheter 2023-04-14

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0458-2026 Abbott Medical 3
Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
Z-0459-2026 Abbott Medical 3
Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400
Z-0491-2025 Abbott Medical 3
Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile
Z-0492-2025 Abbott Medical 3
Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile
Z-0493-2025 Abbott Medical 3
Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, Sterile

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009600098. Last updated year: 2026. Please use registration number 3009600098 when referencing this establishment in official correspondence.
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