510(k) K242909

Device: FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors
Applicant: Edwards Lifesciences, LLC
510(k) number: K242909
Product code: DRS
Decision: Substantially Equivalent (SESE)
Decision date: 2025-03-21
Date received: 2024-09-24
Regulation: 870.2850
Classification name: Transducer, Blood-Pressure, Extravascular
Medical specialty: Cardiovascular
Review panel: Cardiovascular
Device class: 2
Clearance type: Special
Statement or summary: Summary
Third party reviewed: N

Related Records

Applicant Contact

Contact: Aeree Lee
Address: One Edwards Way Irvine CA US 92614 92614

FDA Registration Numbers

2221819
9616675
1218950
1061124
3009156722
3016701404
3012536737
3009077524
3009001657
3008693658
8043983
1718873
3011237704
3005012805
8010042
2648727
2246552
1423537
1721676
3033589330
3006950086
3012307300
3006891665
3004832480
3017636737
1018233
3008403546
1423395
9612152
1422634
1625425
3012542015
1043214
3007048453
3002907620
1055236
3013319212
3016618143
9615817
3015173212
3008496528
3007603826
1713468
1526863
3012528160
2936999
1417592
1649914
1928237
1724474
3007836437
1319639
3007289408
3005595283
9610816
3017987980
3004519921
3003263092
3000126629
3005941719
3005580113
2032112
3016761372
3004605321
3013596024
9616088
3031233007
3004111573
3013500228
3013783488
2015691
8043969
9610849
1054241
2648045
3010421104
3009106351
8020616
3014541700
3015225571

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code DRS

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K221782	Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes	Merit Medical Pte. , Ltd.	2023-03-17
K172458	HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit	Smiths Medical Asd, Inc.	2017-11-09
K163172	HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit	Smiths Medical Asd, Inc.	2017-05-24
K161408	Compass Cast and MAP	Centurion Medical Products Corporation	2016-11-22
K152472	Disposable Pressure Transducer	Zhejiang Haisheng Medical Device Co., Ltd.	2016-10-31
K152980	Flo Trac sensor, Volume View sensor	Edwards Lifesciences, LLC	2016-01-19
K151040	Art-line Single channel blood pressure system, Art-line Double channel blood pressure system, Art-line Triple channel blood pressure system, IAP Monitoring Set with Disposable Transducer	Biometrix , Ltd.	2015-09-04
K133624	COMPASS CT, COMPASS CT PORT	Mirador Biomedical	2014-04-18
K123095	MEDLINE BLOOD PRESSURE TRANSDUCER	Medline Industries, Inc.	2013-05-08
K120624	ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT)	Elcam Medical Acal	2012-06-08
K112203	COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSIST	Mirador Biomedical, Inc.	2011-12-14
K102033	COMBITRANS MONITORING SETS AND ACCESSORIES	B.Braun Melsungen AG	2011-04-07
K103715	COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSURE	Mirador Biomedical, Inc.	2011-01-20
K101189	REAVILLMED PRESSURE MONITORING SYSTEM AND PICC	Reavillmed	2010-12-22
K101518	COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTURE	Mirador Biomedical, Inc.	2010-10-13