Cleared Traditional

K781854 - PAD, B-D I.V. CATH. (FDA 510(k) Clearance)

Dec 1978
Decision
28d
Days
Class 1
Risk

K781854 is an FDA 510(k) clearance for the PAD, B-D I.V. CATH.. This device is classified as a Accessories, Catheter (Class I - General Controls, product code KGZ).

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on December 4, 1978, 28 days after receiving the submission on November 6, 1978.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4200.

Submission Details

510(k) Number K781854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1978
Decision Date December 04, 1978
Days to Decision 28 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code KGZ — Accessories, Catheter
Device Class Class I - General Controls
CFR Regulation 21 CFR 878.4200