Cleared Traditional

Coretech Compression System (Coretech RHB3003)

K250817 · Vive Health, LLC · Cardiovascular
Aug 2025
Decision
143d
Days
Class 2
Risk

About This 510(k) Submission

K250817 is an FDA 510(k) clearance for the Coretech Compression System (Coretech RHB3003), a Sleeve, Limb, Compressible (Class II — Special Controls, product code JOW), submitted by Vive Health, LLC (Naples, US). The FDA issued a Cleared decision on August 8, 2025, 143 days after receiving the submission on March 18, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5800.

Submission Details

510(k) Number K250817 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 2025
Decision Date August 08, 2025
Days to Decision 143 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code JOW — Sleeve, Limb, Compressible
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5800

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