510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QXBClass III

Drug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia

Unknown
FDA source (opens on fda.gov)

QXB is the FDA product code for Drug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia, a class III device type. FDA's definition for this code reads: "dilate prostatic urethra to treat obstructive urinary symptoms associated with benign prostatic hyperplasia". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
QXB
Device name
Drug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia
FDA definition
dilate prostatic urethra to treat obstructive urinary symptoms associated with benign prostatic hyperplasia
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code