(27 days)
The Medtronic® Launcher™ Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The Launcher catheter is intended to be used in the coronary or peripheral vascular system.
The Medtronic Launcher Guide Catheter is constructed with an inner liner, stainless steel braid, outer shaft jacket, sleeve, marker band and a soft distal tip. The inner lumen of the Launcher Guide Catheter has a thin lubricious coating.
The provided document describes a Special 510(k) Notification for the Medtronic 8F Launcher Guiding Catheter. This type of submission is for modifications to a currently cleared device, demonstrating substantial equivalence to a predicate device. As such, the study focuses on functional and material equivalence rather than clinical performance against specific disease detection criteria.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are based on demonstrating substantial equivalence to the predicate device, the Medtronic 7F Launcher Guide Catheter (K022764), in terms of materials, manufacturing processes, design, and performance in in-vitro tests.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993 for external-communicating devices, circulating blood, limited exposure ( |
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).