Panels › Cardiovascular › Product code DTR · Class 2
Heat-Exchanger, Cardiopulmonary Bypass
Regulation 870.4240
1510(k)s in 12 months (91 all time)
2recalls in 12 months (35 all time)
27recalls that name a 510(k)
Top companies in DTR
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 29, 2026 | SPECTRUM MEDICAL SRL Brand Name: Quantum PureFlow
Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8
Model/Catalog Number: HX55W-S0
Software Version: N/A
Product Description: The Quantum PureFlow Standar Open, Classified |
DTR | K220110 K223879 |
| Sep 29, 2026 | SPECTRUM MEDICAL SRL Brand Name: Quantum PureFlow
Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W
Model/Catalog Number: HX55V-S0W
Software Version: N/A
Product Description: The Quantum PureFlow Stan Open, Classified |
DTR | K220110 K223879 |
| May 26, 2023 | Maquet Medical Systems USA QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass
Model Item No.
HMO 30000-USA 701070384
HMO 31000-USA 701070388 Open, Classified |
DTR | K103191 |
| Dec 17, 2019 | Quest Medical, Inc. Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI: (01)2 0634624 81168 7 (11)190916 (17)290913 (10)059135
(The device is a component of the MPS Console used as replacements for worn or damaged Terminated |
DTR | K173716 |
| Dec 2, 2015 | Quest Medical, Inc. Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat exchanger &10 ft. delivery tubing; Model 5001102-AS MPS Delivery Set with 6 ft. delivery tubing; Model 7001102 MPS Low Volum Terminated |
DTR | K953838 |
| Oct 31, 2014 | Terumo Cardiovascular Systems Corp Terumo Cardioplegia Delivery Set-
Item Number: 16130
Product Usage:
The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmona Terminated |
DTR | K823451 |
| Oct 31, 2014 | Terumo Cardiovascular Systems Corp Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass
Item Numbers: 5852, 16010
Product Usage:
This is a Cardioplegia Delivery System that is designed to delivery blood/s Terminated |
DTR | K900640 |
| Oct 31, 2014 | Terumo Cardiovascular Systems Corp Terumo Custom Cardioplegia Delivery Sets
Catalog Code: 204880
Product Usage:
This is a replacement line to multiple Cardioplegia Delivery Sets-and includes the female luer connector" that is the sub Terminated |
DTR | K897039 |
| Mar 10, 2014 | Maquet Cardiovascular Us Sales, Llc MAQUET PLEGIOX Cardioplegia Heat Exchanger
The PLEGIOX Cardioplegia Heat Exchanger is used as part of a cardioplegia system to set and maintain temperature for given flow rates and within the given t Terminated |
DTR | K090555 |
| Apr 8, 2011 | Quest Medical, Inc Quest MPS and MPS 2 Consoles, Quest Medical, Inc., An Atrion company. Single software controlled device that incorporates a pump, a heater/cooler, temperature monitoring, pressure monitoring, a heat Terminated |
DTR | K041979 K953838 |
| Sep 29, 2010 | Terumo Cardiovascular Corporation Cardiovascular Procedure Kit
X-Coated H/L pack with Cardioplegia, Item # 70067-03 Terminated |
DTR | None listed |
| Sep 29, 2010 | Terumo Cardiovascular Corporation Cardiovascular Procedure Kit
Custom 4:1 Myocardial Set, (MP4 w/ Coil Component Utilized), Item # 63485 Terminated |
DTR | None listed |
| Sep 29, 2010 | Terumo Cardiovascular Corporation Cardiovascular Procedure Kit, (MP4 w/ Conducer Component Utilized), labeled in part ***RWJ Hospital***, Item # 71305-03 Terminated |
DTR | K900640 |
| Sep 29, 2010 | Terumo Cardiovascular Corporation Cardiovascular Procedure Kit
X-Coated Pump and Table Pack, Item #71552 Terminated |
DTR | None listed |
| Sep 29, 2010 | Terumo Cardiovascular Corporation Sarns Cardioplegia Set CPLG BLD MP4 4:1
No recirculation, Item # 16010 Terminated |
DTR | None listed |
| Sep 29, 2010 | Terumo Cardiovascular Corporation Sarns Cardioplegia Set with w/ PVC Coil from MP4, Item # 15501 Terminated |
DTR | None listed |
| Sep 29, 2010 | Terumo Cardiovascular Corporation Sarns Cardioplegia Set with Conducer Heat Exchanger Cplg/MP4 4:1, Item # 165720 Terminated |
DTR | None listed |
| Sep 29, 2010 | Terumo Cardiovascular Corporation Sarns Cardioplegia Set Conducer Heat Exchanger Cplg/MP4 4:1 Bridge, Item# 6375 Terminated |
DTR | None listed |
| Aug 2, 2010 | Terumo Cardiovascular Systems Corp Terumo Cardiovascular Procedure Kit Custom
CONDUCER/MP4 8:1 NO RECIRC. DOUBLE SPIKE
P/N: 71032 Terminated |
DTR | K900640 |
| Aug 2, 2010 | Terumo Cardiovascular Systems Corp Terumo Cardiovascular Procedure Kit Custom
X-COATED HEART - LUNG PACK
P/N: 70608-01 Terminated |
DTR | K823451 |
| Aug 2, 2010 | Terumo Cardiovascular Systems Corp Terumo Cardiovascular Procedure Kit Custom
ADULT PACK
P/N: 131351-02 Terminated |
DTR | K823451 |
| Aug 2, 2010 | Terumo Cardiovascular Systems Corp Terumo Cardiovascular Procedure Kit Custom
X-COATED ADULT PACK
P/N 72846 Terminated |
DTR | K823451 |
| Aug 2, 2010 | Terumo Cardiovascular Systems Corp Terumo Cardiovascular Procedure Kit Custom
X-COATED MASTER PACK
P/N 72790 Terminated |
DTR | K823451 |
| Aug 2, 2010 | Terumo Cardiovascular Systems Corp Terumo Cardiovascular Procedure Kit Custom
X-COATED PUMP AND TABLE PACK W/8:1 CARDIOPLEGIA
P/N 72642 Terminated |
DTR | K823451 |
| Aug 2, 2010 | Terumo Cardiovascular Systems Corp Terumo Cardiovascular Procedure Kit Custom
X-COATED PERFUSION PACK
P/N 71934 Terminated |
DTR | K823451 |
| Aug 2, 2010 | Terumo Cardiovascular Systems Corp Terumo Cardiovascular Procedure Kit Custom
X-COATED HEART/LUNG FRAMEPACK
P/N 71766PP Terminated |
DTR | K823451 |
| Aug 2, 2010 | Terumo Cardiovascular Systems Corp Terumo Cardiovascular Procedure Kit Custom
PERFUSION TUBING PACK
P/N 71733 Terminated |
DTR | K823451 |
| Aug 2, 2010 | Terumo Cardiovascular Systems Corp Terumo Cardiovascular Procedure Kit Custom
ADULT PACK
P/N 71546-01 Terminated |
DTR | K823451 |
| Aug 2, 2010 | Terumo Cardiovascular Systems Corp Terumo Cardiovascular Procedure Kit Custom
X-COATED ADULT PRESTIGE PACK
P/N 71544-01 Terminated |
DTR | K823451 |
| Aug 2, 2010 | Terumo Cardiovascular Systems Corp Terumo Cardiovascular Procedure Kit Custom
8:1 CARDIOPLEGIA SET
P/N 70608-01 Terminated |
DTR | K823451 |
| Aug 2, 2010 | Terumo Cardiovascular Systems Corp Terumo Cardiovascular Procedure Kit Custom
MP4, 4:1, PRELIEF, W/RECIRC, COND / PUMP & TABLE PACK
P/N 65503/70881-02 Terminated |
DTR | K823451 |
| Aug 2, 2010 | Terumo Cardiovascular Systems Corp Terumo Cardiovascular Procedure Kit Custom
1:1 CONDUCER/MP4 CRYSTALLOID CARDIOPLEGIA
P/N 65246 Terminated |
DTR | K900640 |
| Aug 2, 2010 | Terumo Cardiovascular Systems Corp Terumo Cardiovascular Procedure Kit Custom
Open Perfusion Pack
P/N 64937 Terminated |
DTR | K823451 |
| Apr 3, 2003 | Terumo Cardiovascular Systems Corp Heat Exchanger Coil (code Number 0006-0011) used in the ''Custom Cardiovascular Procedure Kits'' . Terminated |
DTR | K000977 |
| Mar 20, 2003 | Terumo Cardiovascular Systems Corp Sarns MP4 Cardioplegia Sets; catalog number 15501. Terminated |
DTR | None listed |
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