Vascette HP (hemostatic pad)— 510(k) K220566

Name: FDA 510(k) clearance K220566
Creator: U.S. Food and Drug Administration
Published: 2022-07-29

Substantially Equivalent

Koag, LLC

FDA 510(k) clearance K220566 for Vascette HP (hemostatic pad), Substantially Equivalent on 2022-07-29. Applicant: Koag, LLC. Device class: Unclassified.

Clearance details

Applicant: Koag, LLC
Product code: Code QSY
Device class: Unclassified
Advisory panel: Unknown
Date received: 2022-02-28
Decision date: 2022-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vonore, TN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QSY

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K253017 — BloodSTOP iX Trauma Matrix (TM-iX-20)2026-04-30
K251700 — Ganymede 2cm diameter (FG100300) +14 more2026-02-26
K250319 — MFUSE (MS001)2025-12-15
K253609 — TRAUMAGEL® 2.0 Hemostatic Gel2025-12-12
K240713 — TRAUMAGEL®2024-08-14

Adverse events under product code QSY

product code QSY

Death: 5
Other: 1
Total: 6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.