STAR 55— 510(k) K080173
Substantially EquivalentLarsen & Toubro Limited
FDA 510(k) clearance K080173 for STAR 55, Substantially Equivalent on 2008-02-08. Applicant: Larsen & Toubro Limited.
Clearance details
- Applicant
- Larsen & Toubro Limited
- Product code
- Code MWI
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Schaumburg, IL, US
Adverse events under product code MWI
product code MWI- Death
- 16
- Malfunction
- 963
- Total
- 979
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.