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
2018596287
Device Listing 2018596287
Listing Summary
#
Listing key
2018596287
Premarket submission
K143561
Device
ELM PTA Balloon Dilatation Catheter
Applicant
O'Connell Regulatory Consultants, Inc.
Product code
LIT
Decision date
2015-05-19
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
112049
3005994106
3005994106
Creagh Medical Ltd.
1
N
2026-01-01
IDA Business Park Ballinasloe Co. Galway IE H53 K8P4