Cleared Traditional

K896472 - KEY VASCULAR BOOTIES (FDA 510(k) Clearance)

K896472 · Key Surgical, Inc. · General & Plastic Surgery device
Dec 1989
Decision
31d
Days
Class 1
Risk

K896472 is an FDA 510(k) clearance for the KEY VASCULAR BOOTIES. This device is classified as a Marker, Suture Identification (Class I - General Controls, product code MAW).

Submitted by Key Surgical, Inc. (Minneapolis, US). The FDA issued a Cleared decision on December 14, 1989, 31 days after receiving the submission on November 13, 1989.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K896472 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1989
Decision Date December 14, 1989
Days to Decision 31 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code MAW — Marker, Suture Identification
Device Class Class I - General Controls
CFR Regulation 21 CFR 878.4800