Pti Heart-Chill Pouch/Pad Sling (Sterile)
FDA 510(k) K873924 · Buckman Co., Inc.
510(k) numberK873924
Submission
- Device name
- Pti Heart-Chill Pouch/Pad Sling (Sterile)
- Applicant
- Buckman Co., Inc.
Martinez, CA, US - Received
- September 25, 1987
- Decision date
- February 2, 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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| 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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Questions and answers
When was Pti Heart-Chill Pouch/Pad Sling (Sterile) cleared by the FDA?
Pti Heart-Chill Pouch/Pad Sling (Sterile) (K873924) received a 510(k) decision of Substantially Equivalent on February 2, 1988, 130 days after the submission was received.
What is the product code of K873924?
The FDA product code is DWC – Controller, Temperature, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4250.