DeviceClearance

MaxCap Ped and MaxCap Neo— 510(k) K182362

Substantially Equivalent

Maxtec, LLC

FDA 510(k) clearance K182362 for MaxCap Ped and MaxCap Neo, Substantially Equivalent on 2019-05-23. Applicant: Maxtec, LLC.

Clearance details

Applicant
Maxtec, LLC
Product code
Code CCK
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Salt Lake City, UT, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code CCK

product code CCK
Death
3
Malfunction
11,428
Total
11,431

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.