Medical Device Manufacturer · US , Englewood , CO

Circa Scientific, Inc.

6 submissions · 6 cleared · Since 2023

6

Total

6

Cleared

0

Denied

Circa Scientific, Inc. — FDA 510(k) Submissions

Circa Scientific, Inc. has submitted 6 FDA 510(k) premarket notifications since 2023, of which 6 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Catheter, Septostomy, Introducer, Catheter, Continuous Measurement Thermometer . Use the specialty filter in the sidebar to narrow results.

6 devices

1–6 of 6

CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)

K251007 · DXF Catheter, Septostomy · Cardiovascular

PeriCross? Epicardial Access Kit

K243954 · DYB Introducer, Catheter · Cardiovascular

Cross Wise? Multi-Use RF Adapter Cable

K243193 · DXF Catheter, Septostomy · Cardiovascular

CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002)

K241414 · DXF Catheter, Septostomy · Cardiovascular

CardioCurve 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 Steer

K240004 · DYB Introducer, Catheter · Cardiovascular

CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System

K222311 · FLL Continuous Measurement... · Cardiovascular

Data Source

FDA 510(k) public files . 174,402 total devices indexed.