Cleared Traditional

MINISTIK MINI PUNCTURE SET CATALOG CODE #57505

K871137 · Dlp, Inc. · Cardiovascular
Jul 1987
Decision
118d
Days
Class 2
Risk

About This 510(k) Submission

K871137 is an FDA 510(k) clearance for the MINISTIK MINI PUNCTURE SET CATALOG CODE #57505, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Dlp, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on July 16, 1987, 118 days after receiving the submission on March 20, 1987. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K871137 FDA.gov
FDA Decision Cleared SESE
Date Received March 20, 1987
Decision Date July 16, 1987
Days to Decision 118 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DQX — Wire, Guide, Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1330

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