CATHCOR DESKTOP
FDA 510(k) clearance K002137 · decided 2000-10-05
Clearance details
- K-number
- K002137
- Device name
- CATHCOR DESKTOP
- Applicant
- Siemens Elema AB
- Decision
- Substantially Equivalent
- Date received
- 2000-07-14
- Decision date
- 2000-10-05
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- DQK
- Device class
- 2
- Regulation number
- 870.1425
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Danvers, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Cathcor/LX/Desktop, System, X-Ray, Angiographic recall (Z-1032-03) | Siemens Medical Solutions USA, Inc | 2003-07-19 |