Device Listing 1998574796

Listing Summary#

Listing key
1998574796
Premarket submission
K250706
Device
Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter
Applicant
Biotronik, Inc.
Product code
LIT
Decision date
2025-04-04