Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005)— 510(k) K181725
Substantially EquivalentAvenu Medical, Inc.
FDA 510(k) clearance K181725 for Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005), Substantially Equivalent on 2018-10-05. Applicant: Avenu Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Avenu Medical, Inc.
- Product code
- Code PQK
- Device class
- Class 2
- Regulation
- 21 CFR 870.1252
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Juan Capistrano, CA, US
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More clearances from Avenu Medical, Inc.
view allAdverse events under product code PQK
product code PQK- Death
- 7
- Injury
- 191
- Total
- 198
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.