K910997
Substantially Equivalent - Market after InspectionDATASCOPE PERCOR STAT INTRA-AORTIC BALLOON
- Applicant
- Datascope Corp.
- Product code
- DSP
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent - Market after Inspection
- Clearance type
- Traditional
- Location
- Oakland, NJ, US
Adverse events under product code DSP
product code DSP- Death
- 317
- Injury
- 566
- Malfunction
- 36,831
- Other
- 4
- Total
- 37,718
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.