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
1547736550
Device Listing 1547736550
Listing Summary
#
Listing key
1547736550
Premarket submission
K062446
Device
MODIFICATION TO PINNACLE ROII HIFLOW INTRODUCER SHEATH
Applicant
Terumo Medical Corp.
Product code
DYB
Decision date
2006-10-23
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
12938
1118880
1118880
TERUMO MEDICAL CORP.
1
Y
2026-01-01
950 ELKTON BLVD. ELKTON MD US 21921
124925
3008307705
3008307705
Terumo Medical Canada, Inc.
1
N
2026-01-01
10911 Keele Street Units 2-4 Vaughan Ontario CA L6A 5A6