Expro Elite Snare, Sympro Elite Snare— 510(k) K163307

Substantially Equivalent

Vascular Solutions, Inc.

FDA 510(k) clearance K163307 for Expro Elite Snare, Sympro Elite Snare, Substantially Equivalent on 2017-03-08. Applicant: Vascular Solutions, Inc.. Device class: 2.

Clearance details

Applicant
Vascular Solutions, Inc.
Product code
Code MMX
Device class
Class 2
Regulation
21 CFR 870.5150
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Minneapolis, MN, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code MMX

product code MMX
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 →

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