510(k) K931967
- Device
- HE-30 GOLD
- Applicant
- BENTLEY LABORATORIES, INC.
- 510(k) number
- K931967
- Product code
- DTR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-07-13
- Date received
- 1993-04-21
- Regulation
- 870.4240
- Classification name
- Heat-exchanger, Cardiopulmonary Bypass
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAUL J ZALESKY
- Address
- P.O. Bix 19522 Irvine CA US 92713 92713
FDA Registration Numbers#
- 3010155661
- 3006073153
- 9617601
- 2029275
- 2916596
- 9681834
- 3010163695
- 3016746283
- 3002806603
- 3019807891
- 1649914
- 3011554160
- 1721676
- 3003752502
- 2184009
- 1724474
- 1643817
- 3005941719
- 3017987980
- 2011171
- 1124841
- 1218444
- 1319639
- 3030125051
- 9680841
- 8010026
- 1928237
- 3013267343
- 3002807090
- 8010762
- 1718850
Source Documents#
Other 510(k) Records For Product Code DTR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252541 | Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W | Spectrum Medical S.R.L. | 2026-03-12 |
| K240908 | Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM) | Spectrum Medical , Ltd. | 2025-07-08 |
| K250150 | VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini) | Sorin Group Italia S.R.L. | 2025-05-30 |
| K240190 | MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated | Medtronic | 2024-02-23 |
| K223879 | Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M) | Quara S.R.L. | 2023-04-13 |
| K220110 | Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger | Qura S.R.L | 2022-05-06 |
| K212688 | Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger | Qura S.R.L | 2022-01-10 |
| K201984 | MPS 3 ND Myocardial Protection System | Quest Medical, Inc. | 2020-11-20 |
| K200438 | MPS 3 Myocardial Protection System | Quest Medical, Inc. | 2020-06-19 |
| K173716 | MPS2 Myocardial Protection System Console | Quest Medical, Inc. | 2018-10-01 |
| K162774 | MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface (Bridge System) | Medtronic, Inc. | 2017-02-10 |
| K162958 | MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface with Bridge; MYOtherm XP Cardioplegia Delivery System; MYOtherm XP Cardioplegia Delivery System with Bridge | Medtronic, Inc. | 2017-02-01 |
| K090555 | PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30 | Maquet Cardiopulmonary, AG | 2009-12-23 |
| K081838 | GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING | Gish Biomedical, Inc. | 2009-01-26 |
| K072583 | PLEGIOX CARDIOPLEGIA HEAT EXCHANGER, WITH SAFELINE COATING, MODEL(S) CHX30, BSQ-CHX 30 | Maquet Cardiopulmonary, AG | 2008-04-04 |
Legacy Summary#
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FDA Review#
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