Cleared Traditional

OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006)

K964445 · Dlp, Inc. · Cardiovascular
Jan 1997
Decision
85d
Days
Class 1
Risk

About This 510(k) Submission

K964445 is an FDA 510(k) clearance for the OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006), a Instruments, Surgical, Cardiovascular (Class I — General Controls, product code DWS), submitted by Dlp, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on January 30, 1997, 85 days after receiving the submission on November 6, 1996. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4500.

Submission Details

510(k) Number K964445 FDA.gov
FDA Decision Cleared SESE
Date Received November 06, 1996
Decision Date January 30, 1997
Days to Decision 85 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DWS — Instruments, Surgical, Cardiovascular
Device Class Class I — General Controls
CFR Regulation 21 CFR 870.4500

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