Device Listing 1519050996

Listing Summary

Listing key
1519050996
Premarket submission
K961924
Device
IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM
Applicant
Irvine Biomedical, Inc.
Product code
DRF
Decision date
1997-04-11

Related Registrations

Registration keyRegistrationFEICompanyStatusInitial importerExpirationAddress
593920304041000519796IRVINE BIOMEDICAL. INC.1N2026-01-012375 Morse Ave IRVINE CA US 92614
16195530053341383005334138St. Jude Medical, Cardiology Division, Inc.1Y2026-01-015050 Nathan Lane North Plymouth MN US 55442
12828630084528253008452825Barb Scherber1N2026-01-015050 Nathan Ln N Plymouth MN US 55442
18816930121797283012179728St. Jude Medical1Y2026-01-012305 Walnut Street Roseville MN US 55113