K-number	K250439
Device name	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-ST-H); Catapult Guide Sheath; 5F; 45cm (US-35045-F-ST-H); Catapult Guide Sheath; 5F; 45cm; Hockey Stick (US-35045-F-HS-H); Catapult Guide Sheath; 5F; 45cm; Multipurpose (US-35045-F-MP-H); Ca
Applicant	Contract Medical International, GmbH
Product code	DYB
Device class	Class II
Decision date	Mar 16, 2025
Decision	Substantially Equivalent
Regulation	870.1340

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Catapult Guide Sheath is an introducer sheath system used to introduce interventional and diagnostic devices into peripheral and coronary blood vessels. It consists of a coil-reinforced sheath with a hemostasis valve, side port, dilator, and radiopaque marker to identify the distal end. The device includes a lubricious hydrophilic coating on the outer surface to ease insertion.

Technological characteristics

The modified device differs from its predicate primarily in the hemostasis valve adaptor (HVA) components, where several materials were substituted: polycarbonate replaced with copolyester for the HVA cap and body; copolyester replaced with polycarbonate for the swivel nut; a new silicone O-ring added; acetal replaced with HDPE for stopcock handle; ABS replaced with polypropylene for stopcock cap; and TPU Tecothane replaced with TPU Elastollan for tubing. Design, device features, sterilization method, and mode of operation remain unchanged.

Test standards cited

ISO 10555-1:2013, ISO 11070:2014, ISO 80369-1:2018, ISO 80369-7:2021, EN 13868:2002, IEC 62366-1:2020, ISO 10993 series (biocompatibility), ISO 11135:2014 (sterilization), ISO 11737-1:2018, ASTM F88/F88M-21, ASTM F1980-16, EN 868-5:2018, AAMI TIR42, and USP <788>.

Substantial equivalence argument

The device maintains identical intended use, design architecture, and principle of operation as the predicate. Although the HVA component materials were substituted, these materials are biocompatible, chemically stable, and functionally equivalent alternatives supported by comprehensive testing including mechanical performance, biocompatibility, sterilization validation, and accelerated aging. All performance testing demonstrates the modified device performs comparably to the predicate across critical parameters such as insertion force, valve leakage, flow rate, and structural integrity.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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