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510(k) K874927

PTI HEART-CHILL(TM) CARDIAC INSULATING JACKET by Pioneering Technologies, Inc. — Product Code DWC

K874927 is an FDA 510(k) premarket notification submitted by Pioneering Technologies, Inc. for the device "PTI HEART-CHILL(TM) CARDIAC INSULATING JACKET". The FDA issued a decision of Substantially Equivalent on January 29, 1988. The device falls under product code DWC (Controller, Temperature, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4250. Pioneering Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 1988
Date Received
December 2, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Controller, Temperature, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4250
Review Panel
CV
Submission Type

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Pioneering Technologies, Inc.

  • K922025 — ANASTOMART(TM) CORONARY BYPASS GRAFT MARKERS/MODIF (September 22, 1992)
  • K905175 — PTI ANNULOPLASTY RING(STERILE) (February 14, 1992)
  • K905068 — PTI INTRA-ART (TM) PICK-UP WICKS (December 31, 1991)
  • K910067 — PTI STERNAL CLOSURE WIRE SUTURE (May 6, 1991)
  • K905067 — PTI ANASTOMARK FLEXIBLE CORONARY BYPASS GRAFT (March 18, 1991)
  • K901682 — PTI ANASTOMARK(TM) CORONARY BYPASS GRAFT MARKERS (July 3, 1990)
  • K901815 — MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARY (July 3, 1990)
  • K901531 — PTI INTRA-ARTR REUSABLE CORONARY ARTERY PROBE (June 20, 1990)
  • K901575 — REUSABLE TENS PARAVERTEBRAL PAD #641 BACK ELECTROD (May 2, 1990)
  • K897075 — PTI INTRA-ART(TM) ANSARI SAPHENOUS VEIN HOLDER (April 10, 1990)

Other clearances for product code DWC

  • K220635 — Heater-Cooler System 3T (November 16, 2022)
  • K212657 — Quantum Heater-Cooler (May 6, 2022)
  • K191402 — Heater-Cooler System 3T (February 25, 2020)
  • K140012 — SORIN FLEXTHERM (January 31, 2014)
  • K130300 — HEATER-COOLER UNIT HCU 40 (July 1, 2013)
  • K122813 — HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM (December 18, 2012)
  • K102147 — CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000 (November 19, 2010)
  • K071521 — TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM (November 21, 2007)
  • K052601 — STOCKERT HEATER-COOLER SYSTEM 3T (June 6, 2006)
  • K031544 — HEATER COOLER UNIT, MODEL HCU 30 (August 7, 2003)

FDA data resources