LogoFDA 510(k) Search
K Number
K150201
Device Name
Quick-Cross Extreme Support Catheter, Quick-Cross Select Support Catheter
Manufacturer
SPECTRANETICS, INC.
Date Cleared
2015-02-27

(29 days)

Product Code
DQY,DOY
Regulation Number
870.1250
Type
Special
Panel
CV
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Quick-Cross® Extreme and Select Support Catheters are intended to guide and support a guidewire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

Device Description

Quick-Cross Extreme Support Catheter, Quick-Cross Select Support Catheter

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the Quick-Cross Extreme and Select Support Catheters. The document is an FDA 510(k) clearance letter confirming that the device is substantially equivalent to legally marketed predicate devices for its stated indications for use. It outlines regulatory requirements and contact information but does not include clinical study data or performance metrics.

§ 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).