Device Listing 1284326705

Listing Summary

Listing key
1284326705
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

Related Registrations

Registration keyRegistrationFEICompanyStatusInitial importerExpirationAddress
8393580438923002808050BIOTRONIK AG1N2026-01-01ACKERSTRASSE 6 BULACH Zurich CH CH-8180