HEARTSTRING III PROXIMAL SEAL SYSTEM— 510(k) K080169
Substantially EquivalentGuidant Corporation, Cardiac Surgery
FDA 510(k) clearance K080169 for HEARTSTRING III PROXIMAL SEAL SYSTEM, Substantially Equivalent on 2008-02-08. Applicant: Guidant Corporation, Cardiac Surgery.
Clearance details
- Applicant
- Guidant Corporation, Cardiac Surgery
- Product code
- Code DXC
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
Adverse events under product code DXC
product code DXC- Death
- 14
- Injury
- 442
- Malfunction
- 2,209
- Other
- 1
- Total
- 2,666
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.