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
1701605965
Device Listing 1701605965
Listing Summary
#
Listing key
1701605965
Premarket submission
K170599
Device
SureFlo EVD Catheter
Applicant
Arkis Biosciences, Inc.
Product code
JXG
Decision date
2017-08-31
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
12978
3003418325
3003418325
Integra LifeSciences Corporation
1
Y
2026-01-01
1100 Campus Road Princeton NJ US 08540
218001
3014334038
3014334038
Integra LifeSciences Production Corporation
1
N
2026-01-01
11 Cabot Blvd. Mansfield MA US 02048