Cleared Traditional

K072702 - STRYKER ANTIMIC CATHETER (FDA 510(k) Clearance)

Mar 2008
Decision
177d
Days
Class 2
Risk

K072702 is an FDA 510(k) clearance for the STRYKER ANTIMIC CATHETER. This device is classified as a Catheter, Conduction, Anesthetic (Class II - Special Controls, product code BSO).

Submitted by Stryker Instruments, Instruments Div. (Kalamazoo, US). The FDA issued a Cleared decision on March 19, 2008, 177 days after receiving the submission on September 24, 2007.

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

Submission Details

510(k) Number K072702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2007
Decision Date March 19, 2008
Days to Decision 177 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