HCT Empty EVA Container Pack
FDA 510(k) clearance K190328 · decided 2019-08-15
Clearance details
- K-number
- K190328
- Device name
- HCT Empty EVA Container Pack
- Applicant
- Health Care Technologies
- Decision
- Substantially Equivalent
- Date received
- 2019-02-13
- Decision date
- 2019-08-15
- Days to decision
- 183 days
- Clearance type
- Traditional
- Product code
- KPE
- Device class
- 2
- Regulation number
- 880.5025
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Ashland, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| HCT 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs PER CASE. Dist recall (Z-0936-2023) | Stradis Healthcare | 2023-01-11 |
| HCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Packs PER CASE. recall (Z-0937-2023) | Stradis Healthcare | 2023-01-11 |