Abbott Medical

FDA Device Registration & Listing · Caguas, PR, US · Registration 2648612

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
2648612
FEI Number
2648612
Entity Name
Abbott Medical
City/State/Country
Caguas, PR, US
Establishment Address
LOT 20 B Street, Caguas West Industrial Park, Caguas, PR 00725, US
Establishment Type(s)
Manufacture Medical Device
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
K014161
PMA Number
N/A

All Registered Proprietary Names

FemoStop II Plus FemoStop Gold SJM Tailor™ Annuloplasty Band

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2023-09-20
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2012-10-12
KRH Ring, Annuloplasty Cardiovascular Class 2 870.3800 2007-10-16

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
K253232 ABBOTT MEDICAL Seguin Annuloplasty Ring 2025-10-29

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 2648612. Last updated year: 2026. Please use registration number 2648612 when referencing this establishment in official correspondence.
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