CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ) +7 more— 510(k) K240004

Clearance details

Device name as filed

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

Code DYB

Device class

Class 2

Regulation

21 CFR 870.1340

Advisory panel

Cardiovascular

Date received

2024-01-02

Decision date

2024-01-31

Decision

Substantially Equivalent

Clearance type

Special

Location

Englewood, CO, US

• K253526 — NAMIC Dilator and Sheath2026-07-29
• K261529 — Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C) +2 more2026-07-06
• K261242 — SimplGuide2026-06-25
• K261950 — Health Line Tearaway Introducer2026-06-22
• K261492 — FieldFlex Steerable Sheath2026-06-05

• K251007 — CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)2025-05-01
• K243954 — PeriCross Epicardial Access Kit2025-04-24
• K243193 — Cross Wise Multi-Use RF Adapter Cable2024-11-26
• K241414 — CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C) +1 more2024-09-26
• K222311 — CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System2023-05-25

Death

808

Injury

5,922

Malfunction

16,516

Other

5

Total

23,251

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →