Abbott Vascular

FDA Device Registration & Listing · Menlo Park, CA, US · Registration 3005070406

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
3005070406
FEI Number
3005070406
Entity Name
Abbott Vascular
City/State/Country
Menlo Park, CA, US
Establishment Address
3885 Bohannon Drive, Menlo Park, CA 94025, US
Establishment Type(s)
Manufacture Device in the United States for Export Only
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
N/A
PMA Number
N/A

All Registered Proprietary Names

MitraClip™ and TriClip™ Accessories – Plate MitraClip™ and TriClip™ Accessories – Stabilizer MitraClip™ and TriClip™ Accessories – Lift Steerable Guide Catheter Steerable Guide Catheter TriClip™ G5 Steerable Guide Catheter MitraClip™ G5 Steerable Guide Catheter TriClip G4 Clip Delivery System TriClip G5 Delivery System TriClip XTR Clip Delivery System TriClip NTR Clip Delivery System MitraClip Clip Delivery System MitraClip G4 System MitraClip™ G5 Delivery system MitraClip G4 SCG TriClip Steerable Guide Catheter MitraClip™ G5 Steerable Guide Catheter CPS Direct PL CPS Direct PL VBT Renal Guide Catheter MitraClip Steerable Guide Catheter TriClip™ G5 Steerable Guide Catheter MitraClip G4 Steerable Guide Catheter TriClip Steerable Guide Catheter MitraClip NTR Clip Delivery System MitraClip G4 Clip Delivery System MitraClip XTR Clip Delivery System MitraClip™ G5 Delivery System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QWA Cardiovascular Delivery Catheter System Positioning And Stabilization Device Cardiovascular Class 1 870.3955 2024-11-14
DRA Catheter, Steerable Cardiovascular Class 2 870.1280 2019-07-17
DRA Catheter, Steerable Cardiovascular Class 2 870.1280 2019-07-17
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2025-02-07
NPS Tricuspid Valve Repair Device, Percutaneously Delivered Unknown Class 3 N/A 2024-09-26
NKM Mitral Valve Repair Devices Unknown Class 3 N/A 2013-11-22
DRA Catheter, Steerable Cardiovascular Class 2 870.1280 2024-02-05
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2024-08-29
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2012-05-18
NKM Mitral Valve Repair Devices Unknown Class 3 N/A 2020-03-24

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
K884337 Catheter Research C/O Burditt, Bowles & Radzius MICRO-GUIDE SYSTEM 1989-01-05
K162925 Acutus Medical, Inc. AcQGuide Steerable Sheath 2017-04-06
K221397 ABBOTT MEDICAL MitraClip G4 Steerable Guide Catheter 2022-09-28
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

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 3005070406. Last updated year: 2026. Please use registration number 3005070406 when referencing this establishment in official correspondence.
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