510(k) K240004 ยท DYB Introducer, Catheter
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 ); Card
| Applicant | Circa Scientific, Inc., Englewood CO, US |
| Decision | Substantially Equivalent, Jan 31, 2024 |
| Received | Jan 2, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K240004
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.