Cleared Traditional

K823748 - EXPANDED PTFE PROSTHESIS BLOOD ACCES (FDA 510(k) Clearance)

Feb 1983
Decision
66d
Days
Risk

K823748 is an FDA 510(k) clearance for the EXPANDED PTFE PROSTHESIS BLOOD ACCES..

Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 17, 1983, 66 days after receiving the submission on December 13, 1982.

This device falls under the Gastroenterology & Urology FDA review panel.

Submission Details

510(k) Number K823748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1982
Decision Date February 17, 1983
Days to Decision 66 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary

Device Classification

Product Code
Device Class