ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F— 510(k) K071234
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K071234 for ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F, Substantially Equivalent on 2007-06-29. Applicant: Siemens Medical Solutions USA, Inc..
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Code OBJ
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mountain View, CA, US
Adverse events under product code OBJ
product code OBJ- Death
- 38
- Injury
- 634
- Malfunction
- 3,453
- Total
- 4,125
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.