NLIClass II
Catheter, Angiography, Reprocessed
Cardiovascular · 21 CFR 870.1200
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 events6All time
Recalls1All time
Registered firms0Currently listed
510(k) clearances1All time
Recent MDR events
6 adverse event reports on file
- NADec 1, 2014InjuryStryker Sustainability Solutions Phoenix0002090040-2014-00040
- N/AAug 17, 2012MalfunctionStryker Sustainability Solutions2090040-2012-00022
- N/ADec 16, 2011MalfunctionStryker Sustainability Solutions2090040-2011-00037
- N/ANov 1, 2011MalfunctionStryker Sustainability Solutions2090040-2011-00030
- N/AJan 7, 2011MalfunctionAscent2090040-2011-00001
- N/AOct 5, 2009MalfunctionAscent Healthcare Solutions2090040-2009-00006
Event type breakdown
Malfunction5
Injury1
Recalls
1 recall events for this product code
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
1 clearances for this product code