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
1762870829
Device Listing 1762870829
Listing Summary
#
Listing key
1762870829
Premarket submission
K153541
Device
Coldplay CryoBalloon® Ablation System
Applicant
C2 Therapeutics, Inc.
Product code
GEH
Decision date
2016-01-07
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
85642
2518897
1000080301
PENTAX of America, Inc.
1
Y
2026-01-01
3 Paragon Drive MONTVALE NJ US 07645
222450
3008780134
3008780134
Pentax of America, Inc.
1
N
2020-04-25
303 Convention Way Ste 1 Ste 3 Redwood City CA US 94063