K240004
- 510(k) number
- K240004
- Device name
- 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
- Applicant
- Circa Scientific, Inc. CO · US
- Product code
- DYB — Introducer, Catheter
- Decision date
- 2024-01-31
- Date received
- 2024-01-02
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K240004.pdf
Official FDA record: K240004
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.