VAMP Plus Venous/Arterial Blood Management Protection System— 510(k) K181684

Clearance details

Applicant

Edwards Lifesciences, LLC

Product code

Code KRA

Device class

Class 2

Regulation

21 CFR 870.1210

Advisory panel

Cardiovascular

Date received

2018-06-26

Decision date

2018-11-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Irvine, CA, US

• K254051 — Extroducer Infusion Catheter System2026-09-11
• K261610 — Verge Microcatheter2026-06-11
• K260771 — TruSelect 2.6 Microcatheter2026-05-15
• K250794 — InVera Infusion Device2026-03-12
• K243534 — Micro Catheter2025-07-30

• K251326 — Respiration Rate algorithm2026-06-11
• K253186 — HemoSphere Nano Monitor (HSNANO1)2026-02-24
• K251982 — Edwards MC3 Tricuspid annuloplasty ring (4900)2025-09-23
• K251688 — Carpentier-Edwards Physio Annuloplasty Ring (4450)2025-09-17
• K242518 — Hypertension Prediction Index (HePI) Algorithm2025-05-15

Death

234

Injury

1,029

Malfunction

3,012

Other

2

Total

4,277

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0414-2024 — TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 in (173cm) PXAVMP3: x3 (3cc)/VAMP PXVK0364:(3cc)/VAMP 96in (241cm); PXVK0853: x3 (3cc)/VAMP 76in (193cm); PXVK0996:(3cc)/VAMP 68in (174cm); PXVMP2X21: x2 (3cc)/VAMP; PXVMP2X22: x2 (3cc)/VAMP 63 in (160cm); PXVMP3X32: x3 (3cc)/VAMP 75in (190cm); PXVP0041: (3cc)/VAMP Plus 96in (244cm); PXVP0550: x3 (3cc)/VAMP Plus 91 in (231cm); PXVP1071: x3 (3cc)/VAMP Plus 87in (221cm); PXVP1087: x4(3cc)/VAMP Plus; PXVP2260: (3cc)/VAMP Plus 60in (150cm); PXVP2272: (3cc)/VAMP Plus 72in (180cm); PXVP2284: (3cc)/VAMP Plus 84in (210cm); PXVP2284AT3: (3cc)/VAMP Plus 84in (210cm); PXVP23X3: x3: (3cc)/VAMP Plus; PXVP23X3AT3: x3 (3cc)/VAMP Plus; PXVP2X2AT3: x2 (3cc)/VAMP Plus; PXVPL0111: (3cc)/VAMP Plus 84in (213cm); PXVMP160: 3cc/VAMP 60 in (150cm); PXVMP172: 3cc/VAMP 72in)180cm); PXVMP184:3cc/VAMP 84in (210cm); PXVMP260:3cc/VAMP 60in (150cm); PXVFL10017: (3cc)/VAMP Flex 83in (210cm); PXVP0034: (3cc)/VAMP Plus 87in (220cm); T001691A: (3cc)/VAMP Plus; T001691M: (3cc)/VAMP Plus (215cm); T001744M:(3cc)/VAMP 93in (236 cm); T100671M: x3(3cc)/VAMP Plus (215cm); T001760A :x2(3cc)/VAMP Plus; T001765A: (3cc)/60in (150cm); T005021M: (3cc)/VAMP Flex (195cm); T005089M: x2 (3cc)/VAMP Flex (195 cm) ; T005091M: x3(3cc)/VAMP Flex (195cm); T434501B: x2(3cc)/VAMP 88in (225cm); T440B26B: x2 (3cc)/VAMP 88in (225cm); T450545A: x3 (3cc)/VAMP 75in (190cm); T460241A: (3cc)/VAMP Plus 69in (175cm); T530219D: x2 (3cc)/VAMP Plus 65in (165cm)Class II·Ongoing·Edwards Lifesciences, LLC·20231004

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K181684.