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510(k) K860775

MEDIASTINAL AUTOTRANSFUSION SYSTEM by Cardio Metrics, Inc. — Product Code DTP

K860775 is an FDA 510(k) premarket notification submitted by Cardio Metrics, Inc. for the device "MEDIASTINAL AUTOTRANSFUSION SYSTEM". The FDA issued a decision of Substantially Equivalent on May 28, 1986. The device falls under product code DTP (Defoamer, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4230. Cardio Metrics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1986
Date Received
March 3, 1986
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 Cardio Metrics, Inc.

  • K972762 — CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRES (October 14, 1997)
  • K965140 — CARDIOMETRICS WAVEWIRE/WAVEMAP PRESSURE SYSTEM (August 18, 1997)
  • K951567 — CARDIOMETICS FLOWIRE, SMARTWIRE DOPPLER GUIDE WIRE (October 25, 1996)
  • K961777 — ACCUTRAC XT INTRAVASCULAR GUIDE WIRE (FLOPPY) MODEL 2403/(FLEX) MODEL 2404 (July 31, 1996)
  • K955551 — CARDI0METRICS FLOW WIRE XT DOPPLER GUIDE MODEL 1403, 1404 (February 28, 1996)
  • K954913 — CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE (MODIFICATION) (November 7, 1995)
  • K952562 — CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE (August 29, 1995)
  • K943022 — CARDIOMETRICS FLOWIRE DOPPLER GUIDE WIRE (September 19, 1994)
  • K940984 — CARDIOMETRICS DUALFLOW SWITCH BOX (August 18, 1994)
  • K933320 — CARDIOMETRICS FLOMAP AND FLOMOD ULTRASOUND INSTRUMENT (August 17, 1994)

Other clearances for product code DTP

  • K101186 — AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDI (September 3, 2010)
  • 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)

FDA data resources