Cleared Traditional

K951092 - CATHETER SECUREMENT DEVICE (FDA 510(k) Clearance)

Mar 1995
Decision
15d
Days
Class 2
Risk

K951092 is an FDA 510(k) clearance for the CATHETER SECUREMENT DEVICE. This device is classified as a Catheter, Conduction, Anesthetic (Class II - Special Controls, product code BSO).

Submitted by Baxter Healthcare Corp (Deerfield Lake, US). The FDA issued a Cleared decision on March 24, 1995, 15 days after receiving the submission on March 9, 1995.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5120.

Submission Details

510(k) Number K951092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1995
Decision Date March 24, 1995
Days to Decision 15 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BSO — Catheter, Conduction, Anesthetic
Device Class Class II - Special Controls
CFR Regulation 21 CFR 868.5120