EL2-SERIES BLOOD COLLECTION REERVOIR
FDA 510(k) clearance K930154 · decided 1993-07-01
Clearance details
- K-number
- K930154
- Device name
- EL2-SERIES BLOOD COLLECTION REERVOIR
- Applicant
- Electromedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-01-13
- Decision date
- 1993-07-01
- Days to decision
- 169 days
- Clearance type
- Traditional
- Product code
- DTN
- Device class
- 2
- Regulation number
- 870.4400
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Englewood, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medtronic Blood Collection Reservoir, 40 micron,Catalog/Model # EL240, Medtronic, Inc., Mi recall (Z-0477-2008) | Medtronic Perfusion Systems | 2008-01-26 |