FDA Registration
Active
🇺🇸 United States
Abbott Medical
Reg #: 3007113487
·
FEI: 3007113487
·
Expires 2026
Products
21
Proprietary Names
117
Establishment Types
3
Classifications
21
Registration Details
- Registration Name
- Abbott Medical
- Registration Number
- 3007113487
- FEI Number
- 3007113487
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 177 County Road B East
- City
- Saint Paul
- State
- MN
- ZIP
- 55117
- Country
- US
Regulatory Submissions
- 510(k) Number
- K014161
- PMA Number
- P000039
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 |
|---|---|---|---|---|---|
| Occluder, Patent Ductus, Arteriosus | MAE | Class 3 | Unknown | No | 2015-09-11 |
| Transcatheter Septal Occluder | MLV | Class 3 | Unknown | No | 2015-09-11 |
| Ring, Annuloplasty | KRH | Class 2 | Cardiovascular | No | 2007-10-16 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2017-02-17 |
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 1996-05-14 |
| Device, Vascular, For Promoting Embolization | KRD | Class 2 | Cardiovascular | No | 2017-02-17 |
| System, Appendage Closure, Left Atrial | NGV | Class 3 | Unknown | No | 2021-08-14 |
| 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 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2025-12-01 |
| Prosthesis, Mitral Valve, Percutaneously Delivered | NPU | Class 3 | Unknown | No | 2025-05-27 |
| Mitral Valve Repair Devices | NKM | Class 3 | Unknown | No | 2013-11-22 |
| Cardiovascular Delivery Catheter System Positioning And Stabilization Device | QWA | Class 1 | Cardiovascular | No | 2024-11-14 |
| Aortic Valve, Prosthesis, Percutaneously Delivered | NPT | Class 3 | Unknown | No | 2013-02-26 |
| Catheter, Intravascular Occluding, Temporary | MJN | Class 2 | Cardiovascular | No | 2017-02-17 |
| Holder, Heart-Valve, Prosthesis | DTJ | Class 1 | Cardiovascular | No | 1996-05-14 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2017-02-17 |
| Catheter, Steerable | DRA | Class 2 | Cardiovascular | No | 2024-02-05 |
| Sizer, Heart-Valve, Prosthesis | DTI | Class 1 | Cardiovascular | No | 1996-05-14 |
| Tricuspid Valve Repair Device, Percutaneously Delivered | NPS | Class 3 | Unknown | No | 2024-04-02 |
Proprietary Names
SJM Tailor Annuloplasty Band
Amplatzer TorqVue Delivery System
St. Jude Medical Mechanical Heart Valve Leaflet Tester
AMPLATZER Post-Infarct Muscular VSD Occluder
Amplatzer Vascular Plug (AVP)
Amplatzer Vascular Plug
Amplatzer TorqVue 2 Delivery Sheath
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
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)
Seguin Annuloplasty Ring for Mitral Valve Repair
Amplatzer Guidewire
AMPLATZER Vascular Plug 4
Amplatzer Cardiac Plug (ACP)
Amplatzer Duct Occluder
Amplatzer Duct Occluder II
Amplatzer Piccolo Occluder
Amplatzer TorqVue Exchange 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
MitraClip Clip Delivery System
MitraClip G4 System
MitraClip G5 Delivery system
CPS Excel MediGuide Enabled Guidewire, Model DS2M033, DS2M027, DS2M028, DS2M029, DS2M030
Amplatzer Guidewires
AMPLATZER TorqVue 45x45 Delivery Sheath 80 cm
MitraClip and TriClip Accessories Plate
MitraClip and TriClip Accessories Stabilizer
MitraClip and TriClip Accessories Lift
Amplatzer Trevisio Intravascular Delivery System
AMPLATZER Guidewires
GuideRight GuideWires
Amplatzer Vascular Plug II (AVP II)
TriClip Steerable Guide Catheter
Amplatzer TorqVue LP Delivery System
Amplatzer Piccolo Delivery System
AMPLATZER Sizing Balloon
Attune Flexible Adjustable Annuloplasty Ring
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 Sizing Plate
MitraClip G4 SCG
Amplatzer Muscular VSD Occluder
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
Trifecta Valve with Glide Technology (Trifecta GT)
Trifecta Bioprosthetic Heart Valve
Rigid Saddle Ring
SJM Rigid Saddle Ring
Amplatzer TorqVue LP Catheter
Tendyne Transcatheter Mitral Valve System
Amplatzer TorqVue Delivery System
TriClip G4 System
TriClip G4 Delivery System
TriClip G5 Delivery system
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
TriClip G5 Steerable Guide Catheter
MitraClip G5 Steerable Guide Catheter
Steerable Guide Catheter
AMPLATZER Vascular Plug - II ES
Amulet Steerable Delivery Sheath
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Manufacture Device in the United States for Export Only