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

Cardiac Ablation Percutaneous Catheter

Unknown
FDA source (opens on fda.gov)

LPB is the FDA product code for Cardiac Ablation Percutaneous Catheter, a class III device type. FDA's definition for this code reads: "This product code pertains to cardiac ablation catheters indicated for general indications, treatment of supraventricular tachycardia (svt) and ventricular tachycardia (vt). This product code excludes ablation catheters indicated for treatment of atrial flutter [product code oad] and atrial fibrillation [product code...". As of , FDA records hold no 510(k) clearances under this code and 21 recalls.

Classification record

Product code
LPB
Device name
Cardiac Ablation Percutaneous Catheter
FDA definition
This product code pertains to cardiac ablation catheters indicated for general indications, treatment of supraventricular tachycardia (svt) and ventricular tachycardia (vt). This product code excludes ablation catheters indicated for treatment of atrial flutter [product code oad] and atrial fibrillation [product code oae].
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
21

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 39 companies shown, in name order