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Circa-Scientific

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30094373153009437315CIRCA Scientific, Inc.1N2026-01-0114 Inverness Dr E Ste H-136 Englewood CO US 80112

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1331361872844416K251007CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)DXF2025-05-01
1331361762345836K243954PeriCross™ Epicardial Access KitDYB2025-04-24
1331361521007302K243193Cross Wise™ Multi-Use RF Adapter CableDXF2024-11-26
1331361998326364K241414CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002)DXF2024-09-26
1331361045806529K240004CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ); CardioCurve Steerable Sheath Medium Curl, 40cm (CC-1040M ); CardioCurve Steerable Sheath Large Curl, 40cm (CC-1040L ); CardioCurve Steerable Sheath Small Curl, 61cm (CC-1061S); CardioCurve Steerable Sheath Medium Curl, 61cm (CC-1061M ); CardioCurve Steerable Sheath Large Curl, 61cm (CC-1061L); CardioCurve Steerable Sheath Small Curl, 71cm (CC-1071S ); CardioCurve Steerable Sheath Medium Curl, 71cm (CC-1071M ); CardioCurve SteerDYB2024-01-31
1331361992580845K222311CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring SystemFLL2023-05-25
1331361437393555K210185CardioCurve Steerable SheathDYB2021-07-23
1331361181724695K200943Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring SystemFLL2021-12-17
1331361980890179K112376S-CATH ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEMFLL2011-08-31

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DXF32025-05-01
DYB32025-04-24
FLL32023-05-25

PMN#

GUDID#

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