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510(k) K101186

AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG by Medtronic Perfusion Systems — Product Code DTP

K101186 is an FDA 510(k) premarket notification submitted by Medtronic Perfusion Systems for the device "AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG". The FDA issued a decision of Substantially Equivalent on September 3, 2010. The device falls under product code DTP (Defoamer, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4230. Medtronic Perfusion Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 2010
Date Received
April 28, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Defoamer, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4230
Review Panel
CV
Submission Type

Other clearances by Medtronic Perfusion Systems

  • K240666 — Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurfac (July 10, 2024)
  • K181954 — autoLog IQ Autotransfusion System (August 22, 2018)
  • K123351 — AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE (March 19, 2013)
  • K090869 — MIRCSP (MINIMALLY INVASIVE RETROGRADE CORONARY SINUS PERFUSION) MANUAL INFLATE C (August 27, 2009)
  • K080824 — BIO-CONSOLE 560 (May 7, 2008)
  • K061254 — EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222 (June 23, 2006)
  • K052524 — BIO-MEDICUS MULTI-STAGE VENOUS FEMORAL PERCUTANEOUS KIT (November 22, 2005)
  • K052372 — MC2X MULTI-STAGE VENOUS CANNULA, MODELS 91437, 91437C (September 22, 2005)
  • K051303 — BIO-CONSOLE, MODEL 560 (June 10, 2005)
  • K051040 — HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR (May 24, 2005)

Other clearances for product code DTP

  • K082412 — VENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH BIOLINE COATING, MODE (November 10, 2008)
  • K004046 — COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED (April 26, 2001)
  • K002591 — COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR (September 13, 2000)
  • K990514 — MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR (March 9, 1999)
  • K984322 — DIDECO D920, LILLIPUT 1 TWIN RESERVOIR (March 2, 1999)
  • K962726 — BARD QUANTUM CVR (October 30, 1996)
  • K941654 — SARNS FILTERED VENOUS RESERVIOR MODIFICATION (July 26, 1994)
  • K933496 — MAXIMA FILTERED HARDSHELL RESERVIOR (October 15, 1993)
  • K912915 — SARNS NON-FILTERED VENOUS RESERVOIR (September 25, 1991)
  • K911789 — MINIMAX (TM) HARDSHELL VENOUS RES W/INTE CARD FILT (August 20, 1991)

FDA data resources