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Panels › Cardiovascular › Product code DXO · Class 2

Transducer, Pressure, Catheter Tip

Regulation 870.2870

1510(k)s in 12 months (64 all time)

0recalls in 12 months (10 all time)

9recalls that name a 510(k)

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Top companies in DXO

Company	510(k)s	Recalls
Edwards Lifesciences, LLC	5	9
Millar Instruments, Inc.	7	0
Opsens, Inc.	6	0
Camino Laboratories, Inc.	5	0
Radi Medical Systems AB	4	0
Boston Scientific Corp	3	0
Acist Medical Systems	2	0
Baxter Healthcare Corp	2	0
Becton Dickinson Vascular Access, Inc.	2	0
Deseret Medical, Inc.	2	0

Date	Firm and product	Code	Linked 510(k)
May 26, 2021	Edwards Lifesciences, LLC Edwards TruWave (3 cc)/VAMP Jr, REF: VMP406PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)07460691958746 Terminated	DXO	K142749 K161962
May 26, 2021	Edwards Lifesciences, LLC Edwards TruWave 3 cc/VAMP Jr Kit, REF: VMP426PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)57460691950547 Terminated	DXO	K142749 K161962
May 26, 2021	Edwards Lifesciences, LLC Edwards TruWave (30 cc)/VAMP Jr Kit, REF: VMP306PX, Pressure Monitoring Set, Rx Only, CE, UDI: (01)57460691950370 Terminated	DXO	K142749 K161962
May 26, 2021	Edwards Lifesciences, LLC Edwards VAMP Jr. 6 in (15 cm) REF: VMP306, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691944782 Terminated	DXO	K142749 K161962
May 26, 2021	Edwards Lifesciences, LLC Edwards REF: VJ0990, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691951520 Terminated	DXO	K142749 K161962
May 26, 2021	Edwards Lifesciences, LLC Edwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF: T443952B, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 57460691930174 ***Not Marketed within t Terminated	DXO	K142749 K161962
May 26, 2021	Edwards Lifesciences, LLC Edwards TruWave (30 cc)/VAMP Jr/52 in (132 cm) Kit, REF: PXVJ0711, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 07460691954489 Terminated	DXO	K142749 K161962
May 26, 2021	Edwards Lifesciences, LLC Edwards TruWave (3 cc)/VAMP Jr 48 in (120 cm) Kit, REF: PXVJ356, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 57460691954507 Terminated	DXO	K142749 K161962
Nov 13, 2015	Edwards Lifesciences, LLC Intravascular (IV) Administration Sets, Model No. 54IV12, 54IV22, 54IV32, MK2450, 54IV42, MK132, MK2156, MK2270, MK2292, MK2300, MK2374, MK2394, MK2508, MK2227 Terminated	DXO	None listed
Sep 16, 2015	Edward Lifesciences, Llc Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. A sterile, single-use kit that monitors pressures when attached to pressure monitoring catheters. For use on patients requ Terminated	DXO	K142749

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