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WavelinQ

TVA MEDICAL, INC. · Model FX-001CE · UDI-DI 00868260000211

PQK Prescription
7
510(k) clearances
490
Adverse events (7 deaths)
1
Recalls
5
Facilities

Description

WavelinQ™ 6F endoAVF System

Recalls

DateFirmReason
2019-04-12Bard Peripheral Vascular IncThe firm has become aware of a potential problem with their venous and arterial magnetic catheters may be at risk of experiencing a magnetic deficiency, which may result in the mag

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.