Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)
FDA 510(k) K190282 · Spectrum Medical , Ltd.
510(k) numberK190282
Submission
- Device name
- Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)
- Applicant
- Spectrum Medical , Ltd.
Gloucester, GB - Received
- February 11, 2019
- Decision date
- May 24, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DTQ – Console, Heart-Lung Machine, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4220
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
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|---|---|---|---|
| K232291 | Essenz HLM, Essenz ILBMDTQ · Special | Livanova Deutschland, GmbH | 08/24/2023SE |
| K221895 | Terumo Advanced Perfusion System 1DTQ · Traditional | Terumo Cardiovascular Systems Corporation | 04/18/2023SE |
| K221373 | Essenz HLMDTQ · Traditional | Livanova Deutschland, GmbH | 03/09/2023SE |
| K210130 | Stockert S5 SystemDTQ · Special | Livanova Deutschland, GmbH | 04/05/2021SE |
| K202125 | Century Perfusion SystemDTQ · Traditional | Century Hlm, LLC | 03/07/2021SE |
| K173834 | Quantum Pump ConsoleDTQ · Traditional | Spectrum Medical , Ltd. | 05/25/2018SE |
| K172220 | Advanced Perfusion System 1DTQ · Special | Terumo Cardiovascular Systems Corporation | 08/17/2017SE |
| K163531 | Advanced Perfusion System 1DTQ · Traditional | Terumo Cardiovascular Systems Corporation | 06/07/2017SE |
| K153376 | Advanced Perfusion System 1DTQ · Special | Terumo Cardiovascular Systems Corporation | 12/16/2015SE |
| K151349 | Advanced Perfusion System 1DTQ · Traditional | Terumo Cardiovascular Systems Corporation | 08/27/2015SE |
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Questions and answers
When was Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) cleared by the FDA?
Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) (K190282) received a 510(k) decision of Substantially Equivalent on May 24, 2019, 102 days after the submission was received.
What is the product code of K190282?
The FDA product code is DTQ – Console, Heart-Lung Machine, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4220.