ACS SOFT-TIP CORONARY INFUSION CATH W/SIDE HOLES— 510(k) K883564
Substantially EquivalentAdvanced Cardiovascular Systems, Inc.
FDA 510(k) clearance K883564 for ACS SOFT-TIP CORONARY INFUSION CATH W/SIDE HOLES, Substantially Equivalent on 1988-11-03. Applicant: Advanced Cardiovascular Systems, Inc..
Clearance details
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Product code
- Code DQY
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mountain View, CA, US
Adverse events under product code DQY
product code DQY- Death
- 464
- Injury
- 4,489
- Malfunction
- 13,721
- Other
- 2
- Total
- 18,676
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.