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CardioCurve Steerable Sheath Small Curl, 40cm - CardioCurve Steer

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 - CardioCurve Steer 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