everlinQ endoAVF System— 510(k) DEN160006
UnknownTva Medical, Inc.
FDA 510(k) clearance DEN160006 for everlinQ endoAVF System, Unknown on 2018-06-22. Applicant: Tva Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Tva Medical, Inc.
- Product code
- Code PQK
- Device class
- Class 2
- Regulation
- 21 CFR 870.1252
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Austin, TX, US
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More clearances from Tva 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.