Medical Device Manufacturer · US , S,Mta Clara , CA

Abbott Medical

54 submissions · 54 cleared · Since 2019
54
Total
54
Cleared
0
Denied

Abbott Medical — FDA 510(k) Submissions

Abbott Medical has submitted 54 FDA 510(k) premarket notifications since 2019, of which 54 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Catheter, Percutaneous, Computer, Diagnostic, Programmable, Introducer, Catheter, Reprocessed Intravascular Ultrasound Catheter, Catheter, Intravascular, Diagnostic . Use the specialty filter in the sidebar to narrow results.

54 devices
1–25 of 54
Amplatzer? Trevisio? Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80
K260499 · DQY Catheter, Percutaneous · Cardiovascular
Mar 2026 28d
Armada? 14 NC PTA Catheter
K252512 · LIT Catheter, Angioplasty,... · Cardiovascular
Feb 2026 186d
Assert-IQ (DM5100)
K253516 · MXD Recorder, Event,... · Cardiovascular
Dec 2025 36d
Amplatzer Piccolo? Delivery System (9-PDS-04F-045)
K252417 · DQY Catheter, Percutaneous · Cardiovascular
Dec 2025 138d
Seguin Annuloplasty Ring
K253232 · KRH Ring, Annuloplasty · Cardiovascular
Oct 2025 30d
Amplatzer Guidewire
K250031 · DQX Wire, Guide, Catheter · Cardiovascular
Oct 2025 269d
EnSite? X EP System
K252013 · DQK Computer, Diagnostic,... · Cardiovascular
Sep 2025 90d
EnSite? X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite? X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01)
K251463 · DQK Computer, Diagnostic,... · Cardiovascular
Sep 2025 115d
EnSite? X EP System
K251234 · DQK Computer, Diagnostic,... · Cardiovascular
Jul 2025 99d
Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire
K250552 · DQX Wire, Guide, Catheter · Cardiovascular
Jul 2025 150d
Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)
K242841 · GXI Probe, Radiofrequency Lesion · Neurology
May 2025 250d
ViewFlex? Xtra ICE Catheter; ViewFlex? Eco Reprocessed ICE Catheter; Advisor? HD Grid Mapping Catheter, Sensor Enabled?; Advisor? HD Grid X Mapping Catheter, Sensor Enabled?; Agilis? NxT Steerable Introducer; Agilis? NxT Steerable Introducer Dual-Reach?
K251211 · OBJ Catheter, Ultrasound,... · Cardiovascular
May 2025 35d
ViewFlex? X ICE Catheter, Sensor Enabled?
K251231 · OBJ Catheter, Ultrasound,... · Cardiovascular
May 2025 28d
Amulet? Steerable Delivery Sheath
K250426 · DQY Catheter, Percutaneous · Cardiovascular
Apr 2025 70d
JETi Hydrodynamic Thrombectomy System
K243549 · QEZ Aspiration Thrombectomy... · Cardiovascular
Apr 2025 140d
MitraClip? G5 Steerable Guide Catheter (SGC0801); TriClip? G5 Steerable Guide Catheter (TSGC0801)
K243224 · DQY Catheter, Percutaneous · Cardiovascular
Dec 2024 85d
Agilis NxT Steerable Introducer Dual-Reach
K243493 · DYB Introducer, Catheter · Cardiovascular
Dec 2024 31d
Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire
K240997 · DQX Wire, Guide, Catheter · Cardiovascular
Nov 2024 209d
TriClip Steerable Guide Catheter
K241538 · DQY Catheter, Percutaneous · Cardiovascular
Aug 2024 88d
EnSite? X EP System
K242016 · DQK Computer, Diagnostic,... · Cardiovascular
Aug 2024 30d
Advisor? HD Grid X Mapping Catheter, Sensor Enabled?
K241372 · MTD Catheter, Intracardiac... · Cardiovascular
Jul 2024 55d
Agilis? NxT Steerable Introducer Dual-Reach? (I-V2-MED)
K241370 · DYB Introducer, Catheter · Cardiovascular
Jun 2024 30d
CentriMag? Acute Circulatory Support System
K234118 · QNR Blood Pump For Ecmo,... · Cardiovascular
Jan 2024 29d
JETi?Hydrodynamic Thrombectomy System
K232458 · QEZ Aspiration Thrombectomy... · Cardiovascular
Dec 2023 126d
Amulet? Steerable Delivery Sheath
K232690 · DQY Catheter, Percutaneous · Cardiovascular
Sep 2023 28d
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