DeviceClearance

HLM TUBING SET WITH BIOLINE COATING— 510(k) K080592

Substantially Equivalent

Maquet Cardiopulmonary, AG

FDA 510(k) clearance K080592 for HLM TUBING SET WITH BIOLINE COATING, Substantially Equivalent on 2008-09-11. Applicant: Maquet Cardiopulmonary, AG. Device class: 2.

Clearance details

Applicant
Maquet Cardiopulmonary, AG
Product code
Code DWE
Device class
Class 2
Regulation
21 CFR 870.4390
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Hirrlingen, DE
Download summary PDFView on FDA.gov ↗

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Adverse events under product code DWE

product code DWE
Death
9
Malfunction
754
Total
763

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 K080592

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 K080592.

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