FDA.reportPublic FDA data

Rashmi Bhushan

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30026482303002648230Rashmi Bhushan1N2026-01-018200 Coral Sea St NE, MVS33 Mounds View MN US 55112

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1566571790726095P230017PulseSelect™ Pulsed Field Ablation (PFA) systemQZI2023-12-13
1566571814031394P100010ARCTIC FRONT CRYOCATHETER SYSTEMOAE2010-12-17
1566571734968408P0200457F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEMLPB2003-04-17
1566571272830836K202620FlexCath Advance Steerable Sheath and DilatorDRA2020-11-13
1566571649754675K183174FlexCath Advance Steerable Sheath and DilatorDRA2018-11-26
1566571238498119K163268FlexCath Select Steerable Shealth and DilatorDYB2017-02-02
1566571946775916K142684FlexCath Select Steerable Sheath (10 French)DYB2014-11-06
1566571806194726K123591FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH)DRA2012-12-27
1566571451306923K102176FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10DRA2010-09-01
1566571226833132K081049FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12DRA2008-06-27
1566571931150444
1566572001834721
1566571418628345
1566571824756627

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DRA52020-11-13
DYB22017-02-02
OAE12010-12-17
LPB12003-04-17