DeviceClearance

CENTRIFUGAL PUMP SYSTEM LX/DX VERSION— 510(k) K882758

Substantially Equivalent

3M Health Care, Sarns

FDA 510(k) clearance K882758 for CENTRIFUGAL PUMP SYSTEM LX/DX VERSION, Substantially Equivalent on 1988-10-13. Applicant: 3M Health Care, Sarns. Device class: 2.

Clearance details

Applicant
3M Health Care, Sarns
Product code
Code KFM
Device class
Class 2
Regulation
21 CFR 870.4360
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Ann Arbor, MI, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code KFM

product code KFM
Death
109
Injury
241
Malfunction
1,779
Total
2,129

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 K882758

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 K882758.

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