LEUR TIP CAP, VLT CAP(TM)— 510(k) K945454
Substantially EquivalentMartell Medical Products, Inc.
FDA 510(k) clearance K945454 for LEUR TIP CAP, VLT CAP(TM), Substantially Equivalent on 1995-04-14. Applicant: Martell Medical Products, Inc..
Clearance details
- Applicant
- Martell Medical Products, Inc.
- Product code
- Code JKA
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Murrieta, CA, US
Adverse events under product code JKA
product code JKA- Injury
- 455
- Malfunction
- 26,686
- Other
- 4
- Total
- 27,145
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.