FDA Registration
Active
🇺🇸 United States
Merit Medical Systems, Inc.
Reg #: 3010665433
·
FEI: 3010665433
·
Expires 2026
Products
15
Proprietary Names
32
Establishment Types
2
Classifications
15
Registration Details
- Registration Name
- Merit Medical Systems, Inc.
- Registration Number
- 3010665433
- FEI Number
- 3010665433
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 14646 Kirby Drive
- City
- Houston
- State
- TX
- ZIP
- 77047
- Country
- US
Regulatory Submissions
- 510(k) Number
- K002289
Owner / Operator
- Firm Name
- Merit Medical Systems, Inc.
- Operator Number
- 1721504
- Address
- 1600 West Merit Parkway, --
- City
- South Jordan
- State
- UT
- Postal Code
- 84095
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Esophageal | ESW | Class 2 | General, Plastic Surgery | No | 2011-09-02 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2013-04-05 |
| Catheter, Peritoneal, Long-Term Indwelling | FJS | Class 2 | Gastroenterology, Urology | No | 2012-12-21 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2007-12-07 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2013-11-21 |
| Prosthesis, Tracheal, Expandable | JCT | Class 2 | General, Plastic Surgery | No | 2018-09-26 |
| Device, Measuring, For Panendoscope | FDY | Class 1 | Gastroenterology, Urology | No | 2009-06-11 |
| Fluid Drainage Tray | PXU | Class 1 | General, Plastic Surgery | No | 2020-11-20 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2007-12-07 |
| Trocar | DRC | Class 2 | Cardiovascular | No | 2007-12-07 |
| Catheter, Continuous Flush | KRA | Class 2 | Cardiovascular | No | 2017-09-05 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2003-06-05 |
| Injector And Syringe, Angiographic | DXT | Class 2 | Cardiovascular | No | 2023-03-31 |
| Catheter, Steerable | DRA | Class 2 | Cardiovascular | No | 2017-06-30 |
| Dilator, Vessel, For Percutaneous Catheterization | DRE | Class 2 | Cardiovascular | No | 2007-12-07 |
Proprietary Names
EndoMAXX
SureCross Support Catheter
Flex-Neck Infant Catheter
InQwire Guidewire-Prelude Introducer
HeartSpan Steerable Introducer Sheath
Flex-Neck Extender/Repair Kit
AEROmini Tracheobronchial Stent System
ExxTended Catheter
Alimaxx E
Aero Tracheo Stent and Delivery System
Aerosizer
Aero DV Tracheobronchial Stent System
Pericardiocentesis Catheter Kit
Worley
Impress Angiographic Catheter
Flex-Neck Catheter
ARC Catheter
Advance Angiographic Needle
Majestik Angiographic Needle
Transseptal Needle,HeartSpan Transseptal Needle&Stylet Set,TSX Transseptal Needle,Transseptal Needle&Stylet Set;et al.
Maestro Microcatheter
ReSolve Non-Locking Drainage Catheter
ReSolve Locking Drainage Catheter
One-Step Centesis Catheter
FastBreak Connector
Cen-Step Centesis Catheter
HeartLight Deflectable Sheath
HeartSpan Steerable Sheath Introducer
Concierge Guiding Catheter
Vessel Dilator
HeartSpan Fixed Curve Braided Transseptal Sheath, Braided Guiding Introducer, EZ Cross Introducer Kit; et al.
CardiaGuide Fixed Curve Braided Transseptal Sheath
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device