Reprocessed Heart Stabilizers and Positioners

FDA 510(k) K063844 · Sterilmed, Inc.

Substantially Equivalent

510(k) numberK063844

Submission

Device name
Reprocessed Heart Stabilizers and Positioners
Applicant
Sterilmed, Inc.
Maple Grove, MN, US
Received
December 26, 2006
Decision date
March 15, 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
K070036Reprocessed Medtronic Cardiac Stabilization and Positioning DevicesNQG · Traditional Ascent Healthcare Solutions08/17/2007SE
K070034Reprocessed Guidant Cardiac Stabilization and Positioning DevicesNQG · Traditional Ascent Healthcare Solutions08/17/2007SE

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Questions and answers

When was Reprocessed Heart Stabilizers and Positioners cleared by the FDA?

Reprocessed Heart Stabilizers and Positioners (K063844) received a 510(k) decision of Substantially Equivalent on March 15, 2007, 79 days after the submission was received.

What is the product code of K063844?

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