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510(k) K100451

GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132 by Gambro Renal Products, Inc. — Product Code MPB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2010
Date Received
February 17, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Hemodialysis, Non-Implanted
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
Submission Type

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  • K100364 — GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520 (November 3, 2010)
  • K093608 — GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H (July 29, 2010)
  • K080519 — PRISMAFLEX M150 SET (June 13, 2008)

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  • K120674 — MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER (April 4, 2012)
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