DeviceClearance

NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH— 510(k) K141432

Substantially Equivalent

Maquet Cardiopulmonary, AG

FDA 510(k) clearance K141432 for NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH, Substantially Equivalent on 2014-07-07. Applicant: Maquet Cardiopulmonary, AG. Device class: 2.

Clearance details

Applicant
Maquet Cardiopulmonary, AG
Product code
Code DTN
Device class
Class 2
Regulation
21 CFR 870.4400
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Rastatt De-Bw, DE
Download summary PDFView on FDA.gov ↗

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Adverse events under product code DTN

product code DTN
Death
3
Total
3

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 K141432

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 K141432.

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