FDA Registration
Active
🇺🇸 United States
RAPID MEDICAL INC.
Reg #: 3015531723
·
FEI: 3015531723
·
Expires 2026
Products
7
Proprietary Names
17
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- RAPID MEDICAL INC.
- Registration Number
- 3015531723
- FEI Number
- 3015531723
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 445 South Kimball Avenue, Suite 140
- City
- Southlake
- State
- TX
- ZIP
- 76092
- Country
- US
Regulatory Submissions
- 510(k) Number
- K203625
Owner / Operator
- Firm Name
- Rapid Medical Inc.
- Operator Number
- 10060780
- Address
- 445 South Kimball Avenue, Suite 140
- City
- Southlake
- State
- TX
- Postal Code
- 76092
- Country
- US
- Correspondent
- Ina Gutman
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Neurovascular Embolization | HCG | Class 2 | Neurology | No | 2022-02-23 |
| Device, Vascular, For Promoting Embolization | KRD | Class 2 | Cardiovascular | No | 2022-02-23 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2024-07-14 |
| Guide, Wire, Catheter, Neurovasculature | MOF | Class 2 | Cardiovascular | No | 2024-07-14 |
| Catheter, Thrombus Retriever | NRY | Class 2 | Cardiovascular | No | 2025-11-16 |
| Temporary Embolization Assist Device, Peripheral | QZU | Class 2 | Cardiovascular | No | 2024-03-26 |
| Temporary Coil Embolization Assist Device | PUU | Class 2 | Neurology | No | 2022-02-16 |
Proprietary Names
NumenFR Detachment System
Numen Coil Embolization System
Drivewire 24 Guidewire
Tigertriever 17 Ultra Revascularization Device
BraidE Embolization Assist Device
Tigertriever 13
DriveWire 14 LR
DriveWire 14 SR
Comaneci 17
Comaneci Petit
Comaneci
Tigertriever 13 Revascularization Device
Tigertriever 21 Revascularization Device
Tigertriever 17 Revascularitzation Device
Tigertriever 25 Revascularization Device
Tigertriever
Tigertriever 17
Establishment Types
Complaint File Establishment per 21 CFR 820.198