Cleared Traditional

K241746 - UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF (FDA 510(k) Clearance)

Also includes:

UMED REPROCESSED KENDALL SCD EXPRESS SLEEVE UMED REPROCESSED AIRCAST ELITE CALF CUFF 3040 3050 UMED REPROCESSED CTC VP 501 CALF CUFF UMED REPROCESSED CTC VP 520 FOOT CUFF

K241746 · United Medical Resources, LLC · Cardiovascular device

Oct 2024

Decision

108d

Days

Class 2

Risk

K241746 is an FDA 510(k) clearance for the UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF. This device is classified as a Sleeve, Limb, Compressible (Class II - Special Controls, product code JOW).

Submitted by United Medical Resources, LLC (North Salt Lake, US). The FDA issued a Cleared decision on October 4, 2024, 108 days after receiving the submission on June 18, 2024.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5800.

Submission Details

510(k) Number	K241746 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 18, 2024
Decision Date	October 04, 2024
Days to Decision	108 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Statement