Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing Assembly
FDA 510(k) clearance K230028 · decided 2023-04-03
Clearance details
- K-number
- K230028
- Device name
- Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing Assembly
- Applicant
- Cardinal Health200, LLC
- Decision
- Substantially Equivalent
- Date received
- 2023-01-04
- Decision date
- 2023-04-03
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- JOW
- Device class
- 2
- Regulation number
- 870.5800
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Waukegan, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with recall (Z-1917-2025) | Cardinal Health 200, LLC | 2025-06-06 |
| Kendall SCD Comfort Sleeves Knee Length Small, Pediatric - For use with Kendall SCD SmartF recall (Z-1918-2025) | Cardinal Health 200, LLC | 2025-06-06 |
| Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with Kendall SCD SmartFlow recall (Z-1919-2025) | Cardinal Health 200, LLC | 2025-06-06 |