CPS DIRECT SL II SLITTABLE OUTER CATHETER, MODELS DS2C001, DS2C002, DS2C003, DS2C004, DS2C005— 510(k) K092075
Substantially EquivalentSt. Jude Medical, Cardiac Rhythm Management Divisi
FDA 510(k) clearance K092075 for CPS DIRECT SL II SLITTABLE OUTER CATHETER, MODELS DS2C001, DS2C002, DS2C003, DS2C004, DS2C005, Substantially Equivalent on 2009-08-07. Applicant: St. Jude Medical, Cardiac Rhythm Management Divisi.
Clearance details
- Applicant
- St. Jude Medical, Cardiac Rhythm Management Divisi
- Product code
- Code DQY
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Sylmar, 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.