inforMED
NQJClass IILife-sustaining

Catheter, Hemodialysis, Non-implanted, Ultrafiltration, For Peripheral Use

Gastroenterology, Urology · 21 CFR 876.5540

Dual lumen, non-implanted, peripheral access catheters are inserted in the peripheral arm vein and are indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload.

MDR events7All time
Recalls0All time
Registered firms4Currently listed
510(k) clearances4All time

Recent MDR events

7 adverse event reports on file

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Event type breakdown

Injury5
Malfunction2

Most-reported manufacturers

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Gambro Uf Solutions4Unspecified2Catheter, Hemodialysis, Non-implanted, Ultrafiltration, For Peripheral Use1

Recalls

0 recall events for this product code

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No recalls on file for this product code.

Registered firms

4 firms currently registered for this product code

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510(k) clearances

4 clearances for this product code

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