Cleared Traditional

FETH-R-KATH

K981329 · Epimed International, Inc. · Anesthesiology
Aug 1998
Decision
135d
Days
Class 2
Risk

About This 510(k) Submission

K981329 is an FDA 510(k) clearance for the FETH-R-KATH, a Catheter, Conduction, Anesthetic (Class II — Special Controls, product code BSO), submitted by Epimed International, Inc. (Gloversville, US). The FDA issued a Cleared decision on August 26, 1998, 135 days after receiving the submission on April 13, 1998. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5120.

Submission Details

510(k) Number K981329 FDA.gov
FDA Decision Cleared SESE
Date Received April 13, 1998
Decision Date August 26, 1998
Days to Decision 135 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

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