AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS— 510(k) K110793
Substantially EquivalentAmeco Medical Industries
FDA 510(k) clearance K110793 for AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS, Substantially Equivalent on 2011-12-16. Applicant: Ameco Medical Industries. Device class: 2.
Clearance details
- Applicant
- Ameco Medical Industries
- Product code
- Code MPB
- Device class
- Class 2
- Regulation
- 21 CFR 876.5540
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mason, NH, US
Recent devices under product code MPB
view all- K250836 — 14F Duo-Flow® Side X Side Double Lumen Catheter
- K200426 — Acute Dual Lumen Hemodialysis Catheter
- K192807 — Duo-Flow Side x Side Double Lumen Catheter
- K192302 — Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter
- K163458 — Zenysis Short-Term Dialysis Catheter
More clearances from Ameco Medical Industries
view all- K152819 — Amecath Peripheral inserted Central Venous Catheter Sets
- K131144 — AMECO SHEATH INTRODUCER
- K131814 — AMECATH DUAL LUMEN IMPLANTED HEMODIALYSIS CATHETER
- K123943 — AMECATH DUAL LUMEN HEMODIALYSIS CATHETER
- K110794 — AMECATH CVC AND AMECATH PRESSURE CVC SHORT TERM SINGLE AND MULTI-LUMEN CATHERIZATION KITS
Adverse events under product code MPB
product code MPB- Death
- 18
- Malfunction
- 1,042
- Total
- 1,060
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.