CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM
FDA 510(k) clearance K000842 · decided 2000-06-08
Clearance details
- K-number
- K000842
- Device name
- CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM
- Applicant
- Sims Deltec, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-03-15
- Decision date
- 2000-06-08
- Days to decision
- 85 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 |
|---|---|---|
| Deltec branded CADD-Prizm PCS II ambulatory infusion pump and the CADD-Prizm VIP system am recall (Z-0718-2007) | Smiths Medical MD, Inc. | 2007-04-05 |
| Deltec CADD-Prizm PCS II Ambulatory Infusion Pump with Revision E Software recall (Z-0980-03) | Deltec, Inc | 2003-07-03 |