Skip to content
FDA.report
Public FDA data
NDC
RxNorm
DailyMed
Applications
GUDID
GMDN
PMA
PMN
MAUDE
Recalls
Search FDA.report
Search
Home
Company-Registration
1877029329
Device Listing 1877029329
Listing Summary
#
Listing key
1877029329
Premarket submission
K131627
Device
CATHETER INTRODUCER SHEATH
Applicant
Edwards Lifesciences, LLC
Product code
DYB
Decision date
2014-03-06
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
335141
3031571797
3031571797
ENABLECV, LLC
1
N
2026-01-01
6967 S River Gate Dr. Ste 104 Midvale UT US 84047