HCT Empty EVA Container Pack— 510(k) K190328
Substantially EquivalentHealth Care Technologies
FDA 510(k) clearance K190328 for HCT Empty EVA Container Pack, Substantially Equivalent on 2019-08-15. Applicant: Health Care Technologies. Device class: 2.
Clearance details
- Applicant
- Health Care Technologies
- Product code
- Code KPE
- Device class
- Class 2
- Regulation
- 21 CFR 880.5025
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ashland, MA, US
Recent devices under product code KPE
view allAdverse events under product code KPE
product code KPE- Malfunction
- 1,000
- Other
- 1
- Total
- 1,001
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K190328
K-number listed on FDA's recall record- Z-0936-2023 — HCT 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology.
- Z-0937-2023 — HCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K190328.
Data sourced from openFDA. This site is unofficial and independent of the FDA.