ELITECROSS Support Catheter— 510(k) K150187
Substantially EquivalentCordis Corporation, A Johnson & Johnson Company
FDA 510(k) clearance K150187 for ELITECROSS Support Catheter, Substantially Equivalent on 2015-05-19. Applicant: Cordis Corporation, A Johnson & Johnson Company.
Clearance details
- Applicant
- Cordis Corporation, A Johnson & Johnson Company
- Product code
- Code PDU
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fremont, CA, US
Adverse events under product code PDU
product code PDU- Malfunction
- 793
- Total
- 793
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.