ClearanceBrief
510(k) K250439 ยท DYB Introducer, Catheter

Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide Sheath; 4F; 45cm (US-34045-F-ST-H); Catapult Guide Sheath; 4F; 60cm (US-34060-F-ST-H); Catapult Guide Sheath; 4F; 90cm (US-34090-F-ST-H); Catapult Guide Sheath; 4F; 130cm (US-34130-F-ST-H); Catapult Guide Sheath; 5F; 15cm (US-35015-F-

ApplicantContract Medical International, GmbH, Dresden, DE
DecisionSubstantially Equivalent, Mar 16, 2025
ReceivedFeb 14, 2025
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K250439

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.