FDA Registration
Active
🇮🇱 Israel
RAPID-MEDICAL LTD
Reg #: 3009957947
·
FEI: 3009957947
·
Expires 2026
Products
5
Proprietary Names
13
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- RAPID-MEDICAL LTD
- Registration Number
- 3009957947
- FEI Number
- 3009957947
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Carmel Building POB337
- City
- yokneam Northern
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K233791
Owner / Operator
- Firm Name
- Rapid-Medical
- Operator Number
- 10060398
- Address
- Carmel Building POB337
- City
- yokneam
- State
- Northern
- Postal Code
- 2069205
- Country
- IL
- Correspondent
- Ina Gutman
US Agent
- Business Name
- Healthroad Legal Pllc
- Contact Name
- Kathryn Meintsma
- Address
- 14220 24th street
- City
- Watertown
- State
- MN
- ZIP
- 55388
- Country
- US
- [email protected]
- Phone
- 612 9617541
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Guide, Wire, Catheter, Neurovasculature | MOF | Class 2 | Cardiovascular | No | 2024-07-14 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2024-07-14 |
| Temporary Embolization Assist Device, Peripheral | QZU | Class 2 | Cardiovascular | No | 2024-03-26 |
| Catheter, Thrombus Retriever | NRY | Class 2 | Cardiovascular | No | 2026-03-15 |
| Temporary Coil Embolization Assist Device | PUU | Class 2 | Neurology | No | 2019-05-08 |
Proprietary Names
Drivewire 24 Guidewire
BraidE Embolization Assist Device
Tigertriever 25 Revascularization Device
Drivewire 14 LR (previously Columbus 14 LR)
Drivewire 14 SR (previously Columbus 14 SR)
Tigertriever 13 Revascularization Device
Tigertriever 17 Ultra Revascularization Device
Tigertriever 17 Revascularization Device
Tigertriever 21 Revascularization Device
Tigertriever Revascularization Device
Comaneci
Comaneci 17
Comaneci Petit
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device