EMPTY SOLUTION TRANSFER CONTAINER 1000— 510(k) K843523
Substantially EquivalentPolymer Technology Corp.
FDA 510(k) clearance K843523 for EMPTY SOLUTION TRANSFER CONTAINER 1000, Substantially Equivalent on 1984-10-16. Applicant: Polymer Technology Corp.. Device class: 2.
Clearance details
- Applicant
- Polymer Technology Corp.
- 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
- Whitwater, WI, US
Recent devices under product code KPE
view allMore clearances from Polymer Technology Corp.
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 K843523
K-number listed on FDA's recall record- Z-3240-2017 — SECURE(R) 100mL EMPTY VINYL CONTAINER With 2 Ports - (5 Boxes of 40), REF 58719, STERILE R,
- Z-2261-2016 — Container fill and transfer sets, automatic fill compatible, 250 mL, 500 mL, 1000 mL, 1500 mL, 2000 mL, 3000 mL, or 4000 mL.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K843523.
Data sourced from openFDA. This site is unofficial and independent of the FDA.