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CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ) +8 more models

FDA 510(k)

Class II (US FDA 510(k))

510(k) K240004

by CIRCA Scientific, Inc.

Identifiers

510(k) Number
K240004 FDA 510(k)
FDA Product Code
DYB FDA 510(k)
Models / Variants
CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ) FDA 510(k)
CardioCurve Steerable Sheath Medium Curl, 40cm (CC-1040M ) FDA 510(k)
CardioCurve Steerable Sheath Large Curl, 40cm (CC-1040L ) FDA 510(k)
CardioCurve Steerable Sheath Small Curl, 61cm (CC-1061S) FDA 510(k)
CardioCurve Steerable Sheath Medium Curl, 61cm (CC-1061M ) FDA 510(k)
CardioCurve Steerable Sheath Large Curl, 61cm (CC-1061L) FDA 510(k)
CardioCurve Steerable Sheath Small Curl, 71cm (CC-1071S ) FDA 510(k)
CardioCurve Steerable Sheath Medium Curl, 71cm (CC-1071M ) FDA 510(k)
CardioCurve Steer FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1340 FDA 510(k)
Regulation Number
870.1340 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ) +8 more models by CIRCA Scientific, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 9 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
CIRCA Scientific, Inc.

Sources (1)

  • FDA 510(k) K240004 24 fields · synced Jun 19, 2026