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FDA 510(k), K050808, CORONARY SINUS ACCESS KIT, MODEL KCS8F-01
FDA 510(k), K050808, CORONARY SINUS ACCESS KIT, MODEL KCS8F-01
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510(K) Number: K050808
Device Name: CORONARY SINUS ACCESS KIT, MODEL KCS8F-01
Manufacturer: LARRY BLANKENSHIP
Device Classification Name: Angioscope
Regulation Number: LYK
Classification Product Code: 03/30/2005
Date Received: 07/28/2005
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: CORONARY SINUS ACCESS KIT, MODEL KCS8F-01
Manufacturer: LARRY BLANKENSHIP
Device Classification Name: Angioscope
Regulation Number: LYK
Classification Product Code: 03/30/2005
Date Received: 07/28/2005
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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- Delivery: Approximately 1 to 2 weeks
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