14Fr Low Profile Introducer Kit

The Abiomed 14Fr Low Profile Introducer Kit is a sterile, single-use catheter introducer designed to facilitate vascular access for insertion and removal of the Impella CP Catheter and related devices. It consists of an introducer sheath with a hemostasis valve and three-way stopcock, a tapered dilator with hydrophilic coating, and accessory components including guidewires and adapters.

The subject device is identical to the predicate (K241708) in all key aspects: 14Fr insertion profile, stainless steel-reinforced Pebax sheath, 0.035" guidewire compatibility, 13 and 25 cm lengths, ethylene oxide sterilization, tapered polymer dilator with hydrophilic coating at the tip, and radiopaque sheath with internal metal coil. No design or material changes were made.

Biocompatibility testing was conducted in accordance with ISO 10993-1. Performance testing included visual inspection, dimensional verification, sheath system verification, simulated use testing, packaging validation, leak testing, mechanical testing, coating integrity assessment, particulate analysis, and radiopacity verification.

The subject device is substantially equivalent to the predicate because it is identical in intended use, indications for use, design, general system components, sterilization method, guidewire compatibility, insertion profile, and mechanism of action. The submission was limited to labeling changes only; all previous bench testing from the predicate is applicable, all performance data met acceptance criteria, and no new safety or effectiveness issues were identified.