CORONARY SINUS ACCESS KIT, MODEL KCS8F-01— 510(k) K050808
Substantially EquivalentCardio-Optics, Inc.
FDA 510(k) clearance K050808 for CORONARY SINUS ACCESS KIT, MODEL KCS8F-01, Substantially Equivalent on 2005-07-28. Applicant: Cardio-Optics, Inc..
Clearance details
- Applicant
- Cardio-Optics, Inc.
- Product code
- Code LYK
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boulder, CO, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.