DeviceClearance

Straub Endovascular System— 510(k) K172315

Substantially Equivalent

Straub Medical AG

FDA 510(k) clearance K172315 for Straub Endovascular System, Substantially Equivalent on 2018-04-12. Applicant: Straub Medical AG. Device class: 2.

Clearance details

Applicant
Straub Medical AG
Product code
Code MCW
Device class
Class 2
Regulation
21 CFR 870.4875
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Wangs, CH
Download summary PDFView on FDA.gov ↗

Recent devices under product code MCW

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Adverse events under product code MCW

product code MCW
Death
38
Injury
1,386
Malfunction
2,676
Other
2
Total
4,102

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 K172315

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 K172315.

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