Atlas FDA

PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY

FDA 510(k) clearance K072908 · decided 2008-02-04

Clearance details

K-number
K072908
Device name
PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY
Applicant
Gambro Renal Products
Decision
Substantially Equivalent
Date received
2007-10-12
Decision date
2008-02-04
Days to decision
115 days
Clearance type
Traditional
Product code
KPO
Device class
2
Regulation number
876.5820
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Daytona Beach, FL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy recall (Z-2049-2016)Baxter Healthcare Corp.2016-06-24