NQGClass I
Stabilizer, Heart, Non-compression, Reprocessed
Cardiovascular · 21 CFR 870.4500
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).
MDR events7All time
Recalls0All time
Registered firms2Currently listed
510(k) clearances3All time
Recent MDR events
7 adverse event reports on file
- ACCESSRAIL PLATFORMJun 19, 2018InjuryMaquet / GetingeMW5077944
- MAQUET ACROBAT SUVMar 5, 2018InjuryMaquetMW5075708
- N/AAug 5, 2011InjuryStryker Sustainability Solutions2090040-2011-00013
- N/ANov 4, 2010MalfunctionAscent2090040-2010-00014
- N/AJul 19, 2010MalfunctionAscent Healthcare Solutions2090040-2010-00004
- NAMay 14, 2009OtherAscent Healthcare Solutions2090040-2009-00002
- NAJul 20, 2007InjuryAscent Healthcare Solutions2090040-2007-00010
Event type breakdown
Injury4
Malfunction2
Other1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
2 firms currently registered for this product code
510(k) clearances
3 clearances for this product code
- Ascent Healthcare SolutionsAug 17, 2007
K070036 · REPROCESSED MEDTRONIC CARDIAC STABILIZATION AND POSITIONING DEVICES
- Ascent Healthcare SolutionsAug 17, 2007
K070034 · REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICES
- Sterilmed, Inc.Mar 15, 2007
K063844 · REPROCESSED HEART STABILIZERS AND POSITIONERS