Cleared Traditional

K863284 - I.V. START KIT
(FDA 510(k) Clearance)

K863284 · Welmed Systems, Inc. · General & Plastic Surgery device
Sep 1986
Decision
28d
Days
—
Risk

K863284 is an FDA 510(k) clearance for the I.V. START KIT..

Submitted by Welmed Systems, Inc. (West Swanzey, US). The FDA issued a Cleared decision on September 22, 1986, 28 days after receiving the submission on August 25, 1986.

This device falls under the General & Plastic Surgery FDA review panel.

Submission Details

510(k) Number K863284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received August 25, 1986
Decision Date September 22, 1986
Days to Decision 28 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code —
Device Class —