FDA Registration
Active
🇺🇸 United States
BIOMERICS Advanced Catheter
Reg #: 3012159165
·
FEI: 3012159165
·
Expires 2026
Products
7
Proprietary Names
8
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- BIOMERICS Advanced Catheter
- Registration Number
- 3012159165
- FEI Number
- 3012159165
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 10351 Xylon Avenue N
- City
- Brooklyn Park
- State
- MN
- ZIP
- 55445
- Country
- US
Regulatory Submissions
- 510(k) Number
- K221390
Owner / Operator
- Firm Name
- Biomerics
- Operator Number
- 10042380
- Address
- 6030 W Harold Gatty Drive
- City
- Salt Lake City
- State
- UT
- Postal Code
- 84116
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2023-07-27 |
| Catheter, Percutaneous, Cutting/Scoring | PNO | Class 2 | Cardiovascular | No | 2020-02-25 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2020-06-24 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2020-06-24 |
| Catheter, Intravascular Occluding, Temporary | MJN | Class 2 | Cardiovascular | No | 2020-06-24 |
| Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | OTN | Class 2 | General, Plastic Surgery | No | 2020-06-24 |
| Monitor, Esophageal Motility, Anorectal Motility, And Tube | KLA | Class 2 | Gastroenterology, Urology | No | 2015-11-05 |
Proprietary Names
TalWire
FLEX Scoring Catheter
pREBOA-PRO Catheter
ArcTV Transvaginal Sling System
Mcompass Biofeedback Anorectal Manometry System
Biomerics NLE Access Guidewire
FLEX Vessel Prep System
Sublime Microcatheter
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device