FDA 510(k), K082930, CARDIVA CATALYST III SYSTEM WITH PROTAMINE SULFATE

510(K) Number: K082930
Device Name: CARDIVA CATALYST III SYSTEM WITH PROTAMINE SULFATE
Manufacturer: CARDIVA MEDICAL, INC.
Device Classification Name: Clamp, Vascular
Regulation Number: 870.4450
Classification Product Code: DXC
Date Received: 10/01/2008
Decision Date: 02/13/2009
Regulation Medical Specialty: Cardiovascular

235 pages (210 of 445 original pages are fully redacted)