QuikClot Control+— 510(k) K200167

Substantially Equivalent

Z-Medica, LLC

FDA 510(k) clearance K200167 for QuikClot Control+, Substantially Equivalent on 2020-04-23. Applicant: Z-Medica, LLC. Device class: 2.

Clearance details

Applicant: Z-Medica, LLC
Product code: Code POD
Device class: Class 2
Regulation: 21 CFR 878.4454
Advisory panel: General, Plastic Surgery
Date received: 2020-01-23
Decision date: 2020-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wallingford, CT, US

Download summary PDF View on FDA.gov ↗

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K183190 — NuStat2019-09-25
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More clearances from Z-Medica, LLC

K181641 — QuikClot Radial2018-12-24
K140757 — D2 HEMOSTANTIC DRESSING2014-07-17
K123387 — QUIKCLOT HEMOSTATIC DRESSING2013-04-12

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