Home / 510(k) Clearances / K070036

510(k) K070036

REPROCESSED MEDTRONIC CARDIAC STABILIZATION AND POSITIONING DEVICES by Ascent Healthcare Solutions — Product Code NQG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2007
Date Received
January 3, 2007
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).

Other clearances by Ascent Healthcare Solutions

  • K111600 — REPROCESSED HAND ACTIVATE SEALER/DIVIDER (November 15, 2011)
  • K110189 — REPROCESSED ELECTROSURGICAL INSTRUMENT (July 18, 2011)
  • K100909 — REPROCESSED COMPRESSION SLEEVES (July 23, 2010)
  • K100254 — REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER (May 28, 2010)
  • K100537 — REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FC (May 12, 2010)
  • K100080 — REPROCESSED TROCARS, MODEL B5LT AND CB5LT (March 19, 2010)
  • K093702 — REPROCESSED ULTRASONIC COAGULATING SHEARS (March 4, 2010)
  • K092425 — REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10 (October 21, 2009)
  • K090323 — REPROCESSED ELECTROPHYSIOLOGY CATHETERS (April 1, 2009)
  • K082023 — REPROCESSED ELECTROPHYSIOLOGY CATHETERS (September 16, 2008)

Other clearances for product code NQG

  • K070034 — REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICES (August 17, 2007)
  • K063844 — REPROCESSED HEART STABILIZERS AND POSITIONERS (March 15, 2007)