Reprocessed Medtronic Cardiac Stabilization and Positioning Devices

FDA 510(k) K070036 · Ascent Healthcare Solutions

Substantially Equivalent

510(k) numberK070036

Submission

Device name
Reprocessed Medtronic Cardiac Stabilization and Positioning Devices
Applicant
Ascent Healthcare Solutions
Phoenix, AZ, US
Received
January 3, 2007
Decision date
August 17, 2007
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NQG – Stabilizer, Heart, Non-Compression, Reprocessed
Device class
Class I (low risk)
Regulation
21 CFR 870.4500
Specialty
Cardiovascular

The device is used to stabilize, move, lift, and position the heart during cardiovascular surgery. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

Other 510(k)s with product code NQG

510(k)DeviceApplicantDecision
K070034Reprocessed Guidant Cardiac Stabilization and Positioning DevicesNQG · Traditional Ascent Healthcare Solutions08/17/2007SE
K063844Reprocessed Heart Stabilizers and PositionersNQG · Traditional Sterilmed, Inc.03/15/2007SE

More from Sterilmed, Inc.

510(k)DeviceDecision
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K110189Reprocessed Electrosurgical InstrumentNUJ · Traditional 07/18/2011SE
K100909Reprocessed Compression SleevesJOW · Traditional 07/23/2010SE
K100254Reprocessed CS Bi-Diectional Diagnostic Electrophysiology CatheterNLH · Traditional 05/28/2010SE
K100537Reprocessed Ultrasonic Curved Shears with Torque Wrench and Grip Assist Model FCS9…NLQ · Traditional 05/12/2010SE
K100080Reprocessed Trocars, Model B5LT and CB5LTNLM · Traditional 03/19/2010SE
K093702Reprocessed Ultrasonic Coagulating ShearsNLQ · Traditional 03/04/2010SE
K092425Reprocessed 3D Diagnostic Ultrasound Catheters, Model SNDSTR10OWQ · Traditional 10/21/2009SE
K090323Reprocessed Electrophysiology CathetersNLH · Traditional 04/01/2009SE
K082023Reprocessed Electrophysiology CathetersNLH · Traditional 09/16/2008SE

Questions and answers

When was Reprocessed Medtronic Cardiac Stabilization and Positioning Devices cleared by the FDA?

Reprocessed Medtronic Cardiac Stabilization and Positioning Devices (K070036) received a 510(k) decision of Substantially Equivalent on August 17, 2007, 226 days after the submission was received.

What is the product code of K070036?

The FDA product code is NQG – Stabilizer, Heart, Non-Compression, Reprocessed, a Class I (low risk) device regulated under 21 CFR 870.4500.