Circa Scientific, Inc. · Class II · Cleared Jan 31, 2024
| 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. |
| Product code | DYB |
| Device class | Class II |
| Decision date | Jan 31, 2024 |
| Decision | Substantially Equivalent |
| Regulation | 870.1340 |
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