Clamp, Vascular, Reprocessed
Cardiovascular · 21 CFR 870.4450
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).
Recent MDR events
30 adverse event reports on file
- R-PEAN FCPS 6-1/4 CVD MIRRORSep 3, 2013MalfunctionIntegra York, Pa Inc.2523190-2013-00056
- KELLY CLAMPJul 17, 2013MalfunctionIntegra Lifesciences Corporation3273393
- N/AJul 22, 2010MalfunctionAscent Healthcare Solutions1056128-2010-00045
- N/AJul 14, 2010MalfunctionAscent Halthcare Solutions1056128-2010-00031
- N/AJul 14, 2010MalfunctionAscent Halthcare Solutions1056128-2010-00032
- N/AJul 14, 2010MalfunctionAscent Halthcare Solutions1056128-2010-00035
- N/AJul 14, 2010MalfunctionAscent Halthcare Solutions1056128-2010-00033
- N/AJul 14, 2010MalfunctionAscent Halthcare Solutions1056128-2010-00034
- N/AJul 14, 2010MalfunctionAscent Halthcare Solutions1056128-2010-00036
- N/AJul 14, 2010MalfunctionAscent Halthcare Solutions1056128-2010-00039
Event type breakdown
Recalls
2 recall events for this product code
- Ascent Healthcare Solutions, Inc.TerminatedAug 10, 2010
ASCENT HEALTHCARE SOLUTIONS. Reprocessed Femoral Compression Device, Model 11165.
The FemoStop Devices may fail to inflate or hold pressure. A separation between the dome and arch base prevents the device from maintaining pressure when inflated.
Z-2196-2010 · View FDA record ↗ - Sterilmed IncTerminatedJan 13, 2009
Femoral Compression Device
SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end. A breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable
Z-0557-2009 · View FDA record ↗
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
3 clearances for this product code