DeviceClearance

VAMP Venous/Arterial Blood Management Protection System— 510(k) K161962

Substantially Equivalent

Edwards Lifesciences, LLC

FDA 510(k) clearance K161962 for VAMP Venous/Arterial Blood Management Protection System, Substantially Equivalent on 2016-11-28. Applicant: Edwards Lifesciences, LLC. Device class: 2.

Clearance details

Applicant
Edwards Lifesciences, LLC
Product code
Code KRA
Device class
Class 2
Regulation
21 CFR 870.1210
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Irvine, CA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code KRA

view all

More clearances from Edwards Lifesciences, LLC

view all

Adverse events under product code KRA

product code KRA
Death
234
Injury
1,029
Malfunction
3,012
Other
2
Total
4,277

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

Recalls naming K161962

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161962.

Data sourced from openFDA. This site is unofficial and independent of the FDA.