Pti Heart-Chill(Tm) Cardiac Insulating Jacket
FDA 510(k) K874927 · Pioneering Technologies, Inc.
510(k) numberK874927
Submission
- Device name
- Pti Heart-Chill(Tm) Cardiac Insulating Jacket
- Applicant
- Pioneering Technologies, Inc.
Martinez, CA, US - Received
- December 2, 1987
- Decision date
- January 29, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DWC – Controller, Temperature, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4250
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
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).
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| K220635 | Heater-Cooler System 3TDWC · Traditional | Livanova Deutschland, GmbH | 11/16/2022SE |
| K212657 | Quantum Heater-CoolerDWC · Traditional | Spectrum Medical , Ltd. | 05/06/2022SE |
| K191402 | Heater-Cooler System 3TDWC · Traditional | Livanova Deutschland, GmbH | 02/25/2020SE |
| K140012 | Sorin FlexthermDWC · Special | Sorin Group Deutschland GmbH | 01/31/2014SE |
| K130300 | Heater-Cooler Unit Hcu 40DWC · Traditional | Maquet Cardiopulmonary, AG | 07/01/2013SE |
| K122813 | Hemotherm Model 400CE Cooler/Heater SystemDWC · Traditional | Cincinnati Sub-Zero Products, Inc. | 12/18/2012SE |
| K102147 | Cardioquip Modular Cooler-Heater Model MCH-1000DWC · Traditional | Cardioquip Llp | 11/19/2010SE |
| K071521 | Terumo HX2 Temperature Management SystemDWC · Traditional | Terumo Cardiovascular Systems Corp. | 11/21/2007SE |
| K052601 | Stockert Heater-Cooler System 3TDWC · Traditional | Sorin Group Deutschland GmbH | 06/06/2006SE |
| K031544 | Heater Cooler Unit, Model Hcu 30DWC · Traditional | Jostra AB | 08/07/2003SE |
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| K922025 | Anastomart(Tm) Coronary Bypass Graft Markers/ModifDSY · Traditional | 09/22/1992SE |
| K905175 | Pti Annuloplasty Ring(Sterile)KRH · Traditional | 02/14/1992SE |
| K905068 | Pti Intra-Art (TM) Pick-Up WicksEFQ · Traditional | 12/31/1991SE |
| K910067 | Pti Sternal Closure Wire SutureGAQ · Traditional | 05/06/1991SE |
| K905067 | Pti Anastomark Flexible Coronary Bypass GraftDSY · Traditional | 03/18/1991SE |
| K901815 | Modified Sterilization of Intra-Art(Tm) CoronaryDRE · Traditional | 07/03/1990SE |
| K901682 | Pti Anastomark(Tm) Coronary Bypass Graft MarkersDSY · Traditional | 07/03/1990SE |
| K901531 | Pti Intra-Artr Reusable Coronary Artery ProbeDNP · Traditional | 06/20/1990SE |
| K901575 | Reusable TENS Paravertebral Pad #641 Back ElectrodGXY · Traditional | 05/02/1990SE |
| K897075 | Pti Intra-Art(Tm) Ansari Saphenous Vein HolderDXC · Traditional | 04/10/1990SE |
Questions and answers
When was Pti Heart-Chill(Tm) Cardiac Insulating Jacket cleared by the FDA?
Pti Heart-Chill(Tm) Cardiac Insulating Jacket (K874927) received a 510(k) decision of Substantially Equivalent on January 29, 1988, 58 days after the submission was received.
What is the product code of K874927?
The FDA product code is DWC – Controller, Temperature, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4250.