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510(k) K063844

REPROCESSED HEART STABILIZERS AND POSITIONERS by Sterilmed, Inc. — Product Code NQG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2007
Date Received
December 26, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stabilizer, Heart, Non-Compression, Reprocessed
Device Class
Class I
Regulation Number
870.4500
Review Panel
CV
Submission Type

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).

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  • K152134 — Reprocessed Vessel Sealer (January 15, 2016)
  • K150357 — Reprocessed Electrophysiology Diagnostic Catheters (August 27, 2015)

Other clearances for product code NQG

  • K070034 — REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICES (August 17, 2007)
  • K070036 — REPROCESSED MEDTRONIC CARDIAC STABILIZATION AND POSITIONING DEVICES (August 17, 2007)