Class Class II
Catapult Guide Sheath (K240957)
Description
Catapult Guide Sheath by Contract Medical International, GmbH, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240957
Clearance Date2024-08-14
Clearance TypeSpecial
Product CodeDYB
Regulation Number870.1340
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240957
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Catapult Guide Sheath (K240957) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221914 | Catapult Guide Sheath | Contract Medical International, GmbH | 2022 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250439 | Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult... | Contract Medical International, GmbH | 2025 |
Trace the full predicate network for K240957
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.