Oxygenators #BOS-10, 105, 5S
FDA 510(k) K823456 · Bentley Laboratories, Inc.
510(k) numberK823456
Submission
- Device name
- Oxygenators #BOS-10, 105, 5S
- Applicant
- Bentley Laboratories, Inc.
Walker, MI, US - Received
- November 18, 1982
- Decision date
- December 30, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DTZ – Oxygenator, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4350
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
Other 510(k)s with product code DTZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253838 | Lifemotion Disposable Membrane OxygenatorDTZ · Traditional | Lifemotion Medical Technology Co., Ltd. | 03/16/2026SE |
| K240934 | Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood…DTZ · Traditional | Spectrum Medical S.R.L. | 03/12/2026SE |
| K250821 | Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR)…DTZ · Traditional | Eurosets S.R.L | 12/12/2025SE |
| K242503 | Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)DTZ · Traditional | Eurosets S.R.L | 11/24/2025SE |
| K231982 | Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2DTZ · Traditional | Qura S.R.L | 09/12/2024SE |
| K240666 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface…DTZ · Traditional | Medtronic Perfusion Systems | 07/10/2024SE |
| K241352 | Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT…DTZ · Special | Medtronic, Inc. | 06/12/2024SE |
| K231652 | D100 Kids; D101 KidsDTZ · Special | Sorin Group Italia S.R.L. | 11/16/2023SE |
| K231773 | Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum…DTZ · Traditional | Qura S.R.L | 11/08/2023SE |
| K231414 | CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)DTZ · Traditional | Chalice Medical , Ltd. | 11/01/2023SE |
More from Chalice Medical , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K931967 | HE-30 GoldDTR · Traditional | 07/13/1993SE |
| K913956 | Blood Cardioplegia Heat Exchanger, Model #HE-30DTN · Traditional | 01/17/1992SE |
| K913692 | Venous Reservoir Bag Model No. BMR-250(TM)DTN · Traditional | 11/15/1991SE |
| K903641 | Quick Prime Hemoconcen. No. HQ-7000 and CBP-7000QKDI · Traditional | 11/09/1990SE |
| K894826 | Univox W/Holders, Models Univox-Hl, HLB, HLFDTZ · Traditional | 02/28/1990SE |
| K874867 | Catr(Tm)-H Cardiotomy HolderKPI · Traditional | 02/02/1988SE |
| K874841 | Integrated Membrane Oxygenator W/Cardiotomy FilterDTZ · Traditional | 02/02/1988SE |
| K874618 | Baxter Accuport(Tm) Central Venous CatheterDQR · Traditional | 01/19/1988SE |
| K823359 | Oxygen Consumption Monitor #OCM-0100DRY · Traditional | 01/05/1983SE |
| K823273 | BOS-2S, Spiraflo Bubble Infant Oxygen.DTZ · Traditional | 01/05/1983SE |
Questions and answers
When was Oxygenators #BOS-10, 105, 5S cleared by the FDA?
Oxygenators #BOS-10, 105, 5S (K823456) received a 510(k) decision of Substantially Equivalent on December 30, 1982, 42 days after the submission was received.
What is the product code of K823456?
The FDA product code is DTZ – Oxygenator, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4350.