DeviceClearance

QUADROX-I MICROPORPOROUS MEMBRANE OXGENATOR SERIES AND QUDROX-ID DIFFUSION MEMBRANE OXYGENATORS SERIES— 510(k) K112360

Substantially Equivalent

Maquet Cardiopulmonary, AG

FDA 510(k) clearance K112360 for QUADROX-I MICROPORPOROUS MEMBRANE OXGENATOR SERIES AND QUDROX-ID DIFFUSION MEMBRANE OXYGENATORS SERIES, Substantially Equivalent on 2011-09-15. Applicant: Maquet Cardiopulmonary, AG. Device class: 2.

Clearance details

Applicant
Maquet Cardiopulmonary, AG
Product code
Code DTZ
Device class
Class 2
Regulation
21 CFR 870.4350
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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More clearances from Maquet Cardiopulmonary, AG

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Adverse events under product code DTZ

product code DTZ
Death
182
Injury
422
Malfunction
3,636
Total
4,240

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 K112360

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 K112360.

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