510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K070036Substantially Equivalent

Reprocessed Medtronic Cardiac Stabilization and Positioning Devices

Stryker Sustainability Solutions, Phoenix AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070036 is the FDA 510(k) clearance record for REPROCESSED MEDTRONIC CARDIAC STABILIZATION AND POSITIONING DEVICES, a class I device, cleared for Ascent Healthcare Solutions on under FDA product code NQG (Stabilizer, Heart, Non-Compression, Reprocessed). FDA's definition for product code NQG reads: "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...". FDA records list 88 510(k) clearances for Stryker Sustainability Solutions, from to . As of , FDA records show no recalls naming K070036.

Clearance record

Decision date
Received
(226 days to decision)
Product code
NQG Stabilizer, Heart, Non-Compression, Reprocessed
Regulation
21 CFR 870.4500
Device class
Class I
Review panel
Cardiovascular
Applicant
Ascent Healthcare Solutions 10232 S. 51st St., Phoenix AZ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NQG

Trailing 12 months

FDA records hold no clearances under product code NQG in the trailing twelve months.

FDA records show no clearances under product code NQG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NQG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260