FDA Registration
Active
🇺🇸 United States
Abbott Medical
Reg #: 2135147
·
FEI: 3005334138
·
Expires 2026
Products
22
Proprietary Names
122
Establishment Types
5
Classifications
22
Registration Details
- Registration Name
- Abbott Medical
- Registration Number
- 2135147
- FEI Number
- 3005334138
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5050 NATHAN LANE NORTH
- City
- Plymouth
- State
- MN
- ZIP
- 55442
- Country
- US
Regulatory Submissions
- 510(k) Number
- K022363
- PMA Number
- P200049
Owner / Operator
- Firm Name
- ABBOTT LABORATORIES
- Operator Number
- 1415939
- Address
- 100 ABBOTT PARK RD., D-03Q3, AP52-1
- City
- Abbott Park
- State
- IL
- Postal Code
- 60064
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ring, Annuloplasty | KRH | Class 2 | Cardiovascular | No | 2007-10-16 |
| Device, Vascular, For Promoting Embolization | KRD | Class 2 | Cardiovascular | No | 2017-02-17 |
| Holder, Heart-Valve, Prosthesis | DTJ | Class 1 | Cardiovascular | No | 1996-05-14 |
| System, Appendage Closure, Left Atrial | NGV | Class 3 | Unknown | No | 2021-08-14 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2017-02-17 |
| Heart-Valve, Mechanical | LWQ | Class 3 | Unknown | No | 2007-10-16 |
| Heart-Valve, Non-Allograft Tissue | LWR | Class 3 | Unknown | No | 2007-10-16 |
| Replacement Heart-Valve | DYE | Class 3 | Cardiovascular | No | 2007-10-16 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2017-02-17 |
| Occluder, Patent Ductus, Arteriosus | MAE | Class 3 | Unknown | No | 2015-09-11 |
| Transcatheter Septal Occluder | MLV | Class 3 | Unknown | No | 2015-09-11 |
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 1996-05-14 |
| Sizer, Heart-Valve, Prosthesis | DTI | Class 1 | Cardiovascular | No | 1996-05-14 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2025-12-01 |
| Tricuspid Valve Repair Device, Percutaneously Delivered | NPS | Class 3 | Unknown | No | 2024-04-02 |
| Catheter, Steerable | DRA | Class 2 | Cardiovascular | No | 2019-07-17 |
| Aortic Valve, Prosthesis, Percutaneously Delivered | NPT | Class 3 | Unknown | No | 2021-09-17 |
| Cardiovascular Delivery Catheter System Positioning And Stabilization Device | QWA | Class 1 | Cardiovascular | No | 2024-11-14 |
| Prosthesis, Mitral Valve, Percutaneously Delivered | NPU | Class 3 | Unknown | No | 2025-05-27 |
| Catheter, Intravascular Occluding, Temporary | MJN | Class 2 | Cardiovascular | No | 2017-02-17 |
| Mitral Valve Repair Devices | NKM | Class 3 | Unknown | No | 2013-11-22 |
| Transcatheter Septal Occluder (Ventricular) | OZH | Class 3 | Unknown | No | 2020-09-08 |
Proprietary Names
SJM Tailor Annuloplasty Band
AMPLATZER Vascular Plug 4
Seguin Annuloplasty Ring for Mitral Valve Repair
Masters Series Mechanical Heart Valve Replacement Holder/Rotators (Mitral)
Rigid Holder Handle (Biocor, Biocor Supra, Epic, Epic Supra, Trifecta valve holder handle)
Mechanical Heart Valve Mitral Holder Handle (905 sizer set accessory)
Holder Handle (Biocor, Biocor Supra, Epic, Epic Supra valve holder handle)
Flexible Extension Handle (Replacement) (Tailor and Seguin sizer sets)
Rigid Extension Handle (Tailor, Seguin, Rigid Saddle Ring sizer sets)
Mechanical Heart Valve Standard Holder Handle (905 sizer set accessory)
Mechanical Heart Valve Rigid Holder Handle (905 and 907 sizer set accessory)
Masters HP Series Mechanical Heart Valve Replacement Holder/Rotators (Aortic)
Mechanical Heart Valve Flexible Holder Handle (905 and 907 sizer set accessory)
Holder Handle (Epic Plus and Epic Max)
Regent Mechanical Heart Valve Replacement Holder/Rotators (Aortic)
Holder Handle (Biocor B30 series valve holder handle)
Masters Series Mechanical Heart Valve Replacement Holder/Rotators (Aortic)
Flexible Holder Handle (Biocor, Biocor Supra, Epic, Epic Supra, Trifecta valve holder handle)
Amplatzer TorqVue LP Catheter
Epic Supra Valve (Aortic)
Epic Plus Supra Valve (Aortic)
Epic Plus Valve (Mitral)
Epic Plus Valve (Aortic)
Epic Valve (Mitral)
Epic Max Valve (Aortic)
Epic Valve (Aortic)
Amplatzer Vascular Plug (AVP)
Amplatzer Vascular Plug
Amplatzer Sizing Plate
Amplatzer Piccolo Delivery System
Rigid Saddle Ring
SJM Rigid Saddle Ring
St. Jude Medical Mechanical Heart Valve Leaflet Tester
St. Jude Medical Mechanical Heart Valve Sizer Set
Epic Plus Heart Valve Sizer Set
St. Jude Medical Mechanical Heart Valve Individual Sizer (905 sizer set accessory)
SJM Tailor Annuloplasty Ring Sizer Set
Epic Heart Valve Sizer Set
St Jude Medical Bioprosthetic Heart Valve Sizer Set (Biocor, Biocor Supra, Epic, Epic Supra valve sizer set)
Regent Mechanical Heart Valve Sizer Set
Rigid Saddle Ring Sizer Set
Seguin Annuloplasty Ring Sizer Set
Double-ended Handle Sizer Rings (15mm MHV Sizer)
Mechanical Heart Valve Standard Sizer Ring (905 sizer set accessory)
Epic Max Heart Valve Sizer Set
Amplatzer Cardiac Plug
Amplatzer Amulet Left Atrial Appendage Occluder
Amulet Steerable Delivery Sheath
Amplatzer Guidewire
Amplatzer Muscular VSD Occluder
TriClip G4 System
TriClip G4 Delivery System
TriClip G5 Delivery system
Attune Flexible Adjustable Annuloplasty Ring
AMPLATZER Vascular Plug - II ES
Steerable Guide Catheter
Navitor Loading System
FlexNav Delivery System
FlexNav Loading System
Navitor Transcatheter Aortic Valve
Navitor Titan Transcatheter Aortic Valve
Navitor Loading System - LG+
Portico Transcatheter Aortic Valve
Amplatzer Vascular Plug II (AVP II)
Amplatzer TorqVue 2 Delivery Sheath
Amplatzer Guidewires
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
Amplatzer TorqVue LP Delivery System
MitraClip and TriClip Accessories Plate
MitraClip and TriClip Accessories Stabilizer
MitraClip and TriClip Accessories Lift
Amplatzer TorqVue Delivery System
Amplatzer Trevisio Intravascular Delivery System
Tendyne Retrieval System
Tendyne Delivery System
Tendyne Stand Components
Tendyne Apical Pad
Tendyne Stand
Tendyne Mitral Valve
Tendyne Weight
Tendyne Pad Positioning System
Tendyne Loading System
AMPLATZER Guidewires
GuideRight GuideWires
Masters Series HP Valved Graft with Gelweave Valsalva Technology (VAVGJ)
Masters Series Mechanical Heart Valve with Expanded Polyester Sewing Cuff (Aortic)
Masters Series Aortic Valved Graft with Hemashield Graft Technology (CAVGJ)
Masters Series Mechanical Heart Valve with Expanded Polyester Sewing Cuff (Mitral)
Masters Series Mechanical Heart Valve (Aortic)
Masters Series Mechanical Heart Valve with Hemodynamic Plus (HP) Sewing Cuff (Mitral)
SJM Masters Series Mechanical Heart Valve
Masters Series Mechanical Heart Valve (Mitral)
Masters Series Mechanical Heart Valve with Expanded Hemodynamic Plus (HP) Sewing Cuff (Aortic)
SJM Masters Series Mechanical Heart Valve Mitral Expanded Hemodynamic Plus (HP)
Regent Mechanical Heart Valve
Masters Series Mechanical Heart Valve with PTFE Sewing Cuff (Aortic)
Masters Series Mechanical Heart Valve with Hemodynamic Plus (HP) Sewing Cuff (Aortic)
Masters Series Mechanical Heart Valve with PTFE Sewing Cuff (Mitral)
Regent Mechanical Heart Valve (FlexCuff)
SJM Masters Series Mechanical Heart Valve Aortic Expanded PTFE Cuff
Amplatzer Cardiac Plug (ACP)
Amplatzer Duct Occluder
Amplatzer Duct Occluder II
Amplatzer Piccolo Occluder
Amplatzer TorqVue Exchange System
AMPLATZER TorqVue 45x45 Delivery Sheath 80 cm
Trifecta Valve with Glide Technology (Trifecta GT)
Trifecta Bioprosthetic Heart Valve
AMPLATZER Sizing Balloon
Toronto Valve
MitraClip Clip Delivery System
MitraClip G4 System
MitraClip G5 Delivery system
Amplatzer TorqVue Delivery System
AMPLATZER Post-Infarct Muscular VSD Occluder
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Manufacture Device in the United States for Export Only
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility