AMECATH DUAL LUMEN HEMODIALYSIS CATHETER— 510(k) K123943
Substantially EquivalentAmeco Medical Industries
FDA 510(k) clearance K123943 for AMECATH DUAL LUMEN HEMODIALYSIS CATHETER, Substantially Equivalent on 2013-04-02. Applicant: Ameco Medical Industries. Device class: 2.
Clearance details
- Applicant
- Ameco Medical Industries
- Product code
- Code MSD
- Device class
- Class 2
- Regulation
- 21 CFR 876.5540
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Monroe, CT, US
Recent devices under product code MSD
view allMore 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
- K110794 — AMECATH CVC AND AMECATH PRESSURE CVC SHORT TERM SINGLE AND MULTI-LUMEN CATHERIZATION KITS
- K110793 — AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS
Adverse events under product code MSD
product code MSD- Death
- 67
- Injury
- 545
- Malfunction
- 3,661
- Total
- 4,273
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.