CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP
FDA 510(k) clearance K031361 · decided 2003-05-23
Clearance details
- K-number
- K031361
- Device name
- CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP
- Applicant
- Deltec, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-04-30
- Decision date
- 2003-05-23
- Days to decision
- 23 days
- Clearance type
- Special
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- 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 Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24 recall (Z-0962-2023) | Smiths Medical ASD Inc. | 2023-01-30 |