QWFClass IILife-sustaining
Tubing, Long Term Support Greater Than 6 Hours
Cardiovascular · 21 CFR 870.4100
The tubing and accessories are intended to connect perfusion devices and circulate blood as part of extracorporeal membrane oxygenation lasting longer than 6 hours.
MDR events1All time
Recalls0All time
Registered firms6Currently listed
510(k) clearances1All time
Recent MDR events
1 adverse event reports on file
Event type breakdown
Malfunction1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
6 firms currently registered for this product code
510(k) clearances
1 clearances for this product code