FDA.reportPublic FDA data

Ryan Calabrese

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96121643002806434Ryan Calabrese1N2026-01-018200 Coral Sea St Ne Mounds View MN US 55112

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
58141070994717P790017USCI DILATATION CATHETERLOX1980-03-24
58141157955820P240013Sphere-9 Catheter and Affera Ablation SystemQZI2024-10-24
58141790726095P230017PulseSelect™ Pulsed Field Ablation (PFA) systemQZI2023-12-13
58141366141209P220026Symplicity Spyral™ Renal Denervation SystemQYI2023-11-17
58141091031584P200046Harmony™ TPV SystemNPV2021-03-26
58141906758717P200028DiamondTemp Ablation SystemOAE2021-01-28
58141840090773P190008IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon CatheterPRC2019-11-21
58141509855441P160043RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMNIQ2017-04-28
58141912521580P150033MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEMPNJ2016-04-06
58141016057609P140018VENASEAL CLOSURE SYSTEMPJQ2015-02-20
58142046408222P140010IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and IN.PACT 018 PaclitaxONU2014-12-30
58141343864551P130021MEDTRONIC COREVALVE SYSTEMNPT2014-01-17
58141715533001P110013RESOLUTE MICROTRAC/RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMNIQ2012-02-17
58141598640776P100040VALIANT THORACIC STENT GRAFT SYSTEMMIH2011-04-01
58141783538380P100021MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEMMIH2010-12-16
58141126185707P030009DRIVER OVER-THE-WIRE, RAPID EXCHANGE, AND MULTI-EXCHANGE CORONARY STENT SYSTEMSMAF2003-10-01
58141851911963K252390Telescope Guide Extension CatheterDQY2025-10-29
58141785998478K250787Liberant Thrombectomy SystemQEW2025-06-11
58141909688593K250558SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315)DQY2025-03-27
58141947743706K232321FlexCath Contour™ Steerable SheathDRA2023-10-31
58141953457577K222873Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery systemDQY2022-11-07
58141385785360K212027TurboHawk Plus Directional Atherectomy SystemMCW2021-08-24
58141445211045K192712Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left Heart Delivery System, Attain Comman + SureValve Guide Catheters for Left Heart Delivery, C315 Delivery CatheterDQY2020-08-03
58141315996195K183493SelectSite C304-HIS Deflectable Catheter SystemDQY2019-03-15
58141748009245K183353Telescope Guide Extension CatheterDQY2019-03-22
58141882649965K182957Heli-FX EndoAnchor SystemOTD2018-11-21
58141943483887K181817transGlideXT Expandable IntroducerDYB2019-03-26
58141460978462K171427Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor CassetteOTD2017-06-13
58141082791189K170191SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision SystemMCW2017-06-16
58141563783015K161361HawkOne Directional Atherectomy SystemMCW2016-10-14
58141817382831K152054Confida Adaptive SheathDYB2015-08-07
58141242335099K143480Euphora Rapid Exchange Balloon Dilatation CatheterLOX2015-04-02
58141767582409K141801HAWKONE DIRECTIONAL ATHERECTOMY SYSTEMMCW2014-10-16
58141111897180K141090NC EUPHORA RAPID EXCHANGE BALLOON DILATATION CATHETERLOX2014-08-15
58141427183200K132030MICRA INTRODUCER SHEATH WITH HYDROPHILIC COATINGDYB2013-09-27
58141175307164K123153ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE CATHETERS FOR LEFT HEART DELIVERY,ATTAIN SELECTDQY2013-04-09
58141581507080K121219ATTAIN CLARITY 6225 VENOGRAM BALLOON CATHETERDQY2012-09-25
58141024187200K112917ATTAIN LDS 6216A LEFT HEART DELIVERY SYSTEM, ATTAIN ACCESS 6218A LEFT HEART DELIVERY SYSTEM, ATTAIN 6216A AND 6218A GUIDDQY2011-10-27
58141331710639K111723TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEMMCW2011-10-27
58141004329947K110560MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETERJXG2011-11-18
58141603047240K103618TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEMMCW2011-01-05
58142038271890K103095SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOONLOX2010-10-22
58141505440015K101885MEDTRONIC C315 DELIVERY CATHETERDQY2010-09-09
58141719415711K093301TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEMMCW2009-11-06
58141516000906K090659ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND GUIDE CATHETERS FOR LEFT HEART DELIVERYDQY2009-03-26
58141599208892K071432SILVERHAWK-R PERIPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USEMCW2008-02-12
58141880603002K061480ATTAIN 6227DEF DEFLECTABLE CATHETER DELIVERY SYSTEMDQY2006-08-21
58141985387754K061416SELECTSITE C304 DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59, C304-L69, C304-XS59 & C304-XL74DQY2006-10-25
58141361290882K061188SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEMMCW2006-10-23
58142031792824K053460MODIFICATION TO SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550, 04800, 05200, 06002, 02406, 04706, 04300,MCW2006-01-13
58141172954763K053431ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEMDQY2006-03-16
58141138681535K050038RELIANT STENT GRAFT BALLOON CATHETERDQY2005-04-13
58141317792806K043553SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550,04800, 05200, 02406, 04706, 04300MCW2005-02-18
58141191017009K024035ATTAIN 6218A-AM AMPLATZ GUIDE CATHETER FOR LEFT-HEART DELIVERYDQY2002-12-30
58141981203358K024032ATTAIN 6216A-MP MULTI-PURPOSE GUIDE CATHETER FOR LEFT-HEART DELIVERYDQY2002-12-30
58141530415577K021589ATTAIN ACCESS 6218A LEFT-HEART DELIVERY SYSTEM, MODEL 6218DQY2002-05-30
58141860467918K021587ATTAIN LDS 6216A LEFT-HEART DELIVERY SYSTEM, MODEL 6216ADQY2002-05-30
58141878348780

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DQY192025-10-29
MCW112021-08-24
LOX42015-04-02
DYB32019-03-26
OTD22018-11-21
NIQ22017-04-28
PJQ22015-02-20
MIH22011-04-01
QEW12025-06-11
DRA12023-10-31
NPV 12021-03-26
OAE 12021-01-28
PRC12019-11-21
PNJ12016-04-06
ONU12014-12-30
NPT12014-01-17
JXG12011-11-18
MAF12003-10-01