510(k) K070034

Device: REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICES
Applicant: ASCENT HEALTHCARE SOLUTIONS
510(k) number: K070034
Product code: NQG
Decision: Substantially Equivalent (SESE)
Decision date: 2007-08-17
Date received: 2007-01-03
Regulation: 870.4500
Classification name: Stabilizer, Heart, Non-compression, Reprocessed
Medical specialty: Cardiovascular
Review panel: Cardiovascular
Device class: 1
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: KATIE BRAY
Address: 10232 S. 51st St. Phoenix AZ US 85044 85044

FDA Registration Numbers#

2011171

Source Documents#

Other 510(k) Records For Product Code NQG #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K070036	REPROCESSED MEDTRONIC CARDIAC STABILIZATION AND POSITIONING DEVICES	Ascent Healthcare Solutions	2007-08-17
K063844	REPROCESSED HEART STABILIZERS AND POSITIONERS	Sterilmed, Inc.	2007-03-15

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases