QLZClass II
Septostomy Catheter, Reprocessed
Cardiovascular · 21 CFR 870.5175
To create or enlarge an atrial septal defect in the heart.
MDR events1All time
Recalls0All time
Registered firms2Currently listed
510(k) clearances2All 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
2 firms currently registered for this product code
510(k) clearances
2 clearances for this product code