Heiter 3000 Hyperthermic Perfusion System
FDA 510(k) K102900 · Hei, Inc.
510(k) numberK102900
Submission
- Device name
- Heiter 3000 Hyperthermic Perfusion System
- Applicant
- Hei, Inc.
Boulder, CO, US - Received
- September 30, 2010
- Decision date
- March 21, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LGZ – Warmer, Thermal, Infusion Fluid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
Other 510(k)s with product code LGZ
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|---|---|---|---|
| K260988 | °M Warmer System with °M StationLGZ · Special | Mequ A/S | 04/24/2026SE |
| K252636 | Fluido Compact SystemLGZ · Traditional | The Surgical Company International B.V. | 11/18/2025SE |
| K251733 | Fluido® AirGuard SystemLGZ · Traditional | The Surgical Company International BV (As Tsc… | 09/04/2025SE |
| K232107 | °M Warmer SystemLGZ · Traditional | Mequ A/S | 05/31/2024SE |
| K211618 | Fluido Compact Blood and Fluid Warming SystemLGZ · Traditional | The Surgical Company International B.V. | 06/05/2023SE |
| K211800 | Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite…LGZ · Traditional | Quality IN Flow , Ltd. | 12/08/2022SE |
| K202461 | ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion SystemLGZ · Traditional | Smisson-Cartledge Biomedical, LLC | 08/12/2022SE |
| K213191 | S-LineLGZ · Traditional | Barkey GmbH & Co. KG | 05/24/2022SE |
| K192325 | Quantum Blood and Fluid Warming SystemLGZ · Special | Life Warmer, Inc. | 10/18/2019SE |
| K180842 | MAC Medical D-Series Blanket and Solution Warming CabinetsLGZ · Traditional | Mac Medical, Inc. | 03/05/2019SE |
Questions and answers
When was Heiter 3000 Hyperthermic Perfusion System cleared by the FDA?
Heiter 3000 Hyperthermic Perfusion System (K102900) received a 510(k) decision of Substantially Equivalent on March 21, 2012, 538 days after the submission was received.
What is the product code of K102900?
The FDA product code is LGZ – Warmer, Thermal, Infusion Fluid, a Class II (moderate risk) device regulated under 21 CFR 880.5725.