CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400
FDA 510(k) clearance K982838 · decided 1998-11-04
Clearance details
- K-number
- K982838
- Device name
- CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400
- Applicant
- Sims Deltec, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-08-12
- Decision date
- 1998-11-04
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- FRN
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- St. Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smith recall (Z-0307-2018) | Smiths Medical ASD Inc. | 2018-01-02 |
| CADD-LEGACY 1 Model 6400, Ambulatory Infusion Pump, REF 21-6400-51, Rx Only, Smiths Medica recall (Z-1235-2010) | Smiths Medical ASD, Inc. | 2010-04-05 |