MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULE
FDA 510(k) clearance K033881 · decided 2004-03-02
Clearance details
- K-number
- K033881
- Device name
- MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULE
- Applicant
- Medrad, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-12-15
- Decision date
- 2004-03-02
- Days to decision
- 78 days
- Clearance type
- Special
- Product code
- DXT
- Device class
- 2
- Regulation number
- 870.1650
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Indianola, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Stellant CT Injection System. Powered Injector with Syringe. Angiographic Injector and Syr recall (Z-0154-06) | Medrad Inc | 2005-11-16 |