FDA Registration
Active
🇺🇸 United States
IMPERATIVE CARE INC.
Reg #: 3014590708
·
FEI: 3014590708
·
Expires 2026
Products
8
Proprietary Names
31
Establishment Types
3
Classifications
8
Registration Details
- Registration Name
- IMPERATIVE CARE INC.
- Registration Number
- 3014590708
- FEI Number
- 3014590708
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1359 Dell Ave
- City
- Campbell
- State
- CA
- ZIP
- 95008
- Country
- US
Regulatory Submissions
- 510(k) Number
- K242672
Owner / Operator
- Firm Name
- Imperative Care Inc.
- Operator Number
- 10058493
- Address
- 1359 Dell Ave
- City
- Campbell
- State
- CA
- Postal Code
- 95008
- Country
- US
- Correspondent
- Michael Wong
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Thrombus Retriever | NRY | Class 2 | Cardiovascular | No | 2025-01-27 |
| Peripheral Mechanical Thrombectomy With Aspiration | QEW | Class 2 | Cardiovascular | No | 2025-06-10 |
| Catheter, Continuous Flush | KRA | Class 2 | Cardiovascular | No | 2025-06-10 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2025-09-08 |
| Guide, Wire, Catheter, Neurovasculature | MOF | Class 2 | Cardiovascular | No | 2025-09-08 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2021-09-20 |
| Catheter, Percutaneous, Neurovasculature | QJP | Class 2 | Cardiovascular | No | 2021-09-20 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2024-04-22 |
Proprietary Names
Zoom 88 Large Distal Platform
Zoom 88 Large Distal Platform Support
Zoom (71, 55, 45, 35) Catheters
Zoom POD Aspiration Tubing
TracStar LDP Large Distal Platform
Zoom Aspiration Tubing
Zoom System
Zoom Reperfusion Catheter
Symphony Thrombectomy System
ZOOM Aspiration Tubing
ZOOM Reperfusion Catheter
ZOOM Aspiration Catheter
Ikon Guidewire
X-Wire Guidewire
Zoom 88 LDP Catheter
TracStar LDP Catheter
Zoom System (Zoom 4S Catheter)
Zoom 6F Insert Catheters
Zoom 88 LDP Support Catheter
Truvic Medical Inc. Prodigy Thrombectomy System
Imperative Care, Inc. Prodigy Thrombectomy System
TRX Long Sheath
TracStar Large Distal Platform
ZOOM 88 Large Distal Platform
ZOOM 88-T Large Distal Platform
Zoom RDL Radial Access System
Symphony 16F 82cm Thrombectomy System
Zoom 88 Support Large Distal Platform
Zoom 7X Catheter
Imperative Care, Inc. Symphony Thrombectomy System
TRUVIC Medical Inc. Symphony Thrombectomy System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility