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510(k) K070666

GENESISCS COMPONENT CONCENTRATING SYSTEM by Perfusion Partners & Assoc., Inc. — Product Code JQC

K070666 is an FDA 510(k) premarket notification submitted by Perfusion Partners & Assoc., Inc. for the device "GENESISCS COMPONENT CONCENTRATING SYSTEM". The FDA issued a decision of Substantially Equivalent on June 20, 2007. The device falls under product code JQC (Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use), a Class I device regulated under 21 CFR 862.2050. Perfusion Partners & Assoc., Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2007
Date Received
March 12, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Device Class
Class I
Regulation Number
862.2050
Review Panel
CH
Submission Type

Other clearances by Perfusion Partners & Assoc., Inc.

  • K024080 — SECQUIRE CELL SEPARATOR (July 2, 2003)

Other clearances for product code JQC

  • K183205 — PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiol (May 30, 2019)
  • K103340 — SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM (December 6, 2010)
  • K081345 — AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY) (July 10, 2008)
  • K071934 — MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT (October 11, 2007)
  • K052925 — SMARTPREP2 CENTRIFUGE SYSTEM (January 4, 2006)
  • K042473 — COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM (November 19, 2004)
  • K024080 — SECQUIRE CELL SEPARATOR (July 2, 2003)
  • K030340 — AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129) (April 11, 2003)
  • K030555 — GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A (April 11, 2003)
  • K021902 — MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET SEPA (August 12, 2002)

FDA data resources