Cleared Traditional

INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054

K100518 · Instrumed International, Inc. · Cardiovascular
Aug 2010
Decision
189d
Days
Class 2
Risk

About This 510(k) Submission

K100518 is an FDA 510(k) clearance for the INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054, a Dilator, Vessel, Surgical (Class II — Special Controls, product code DWP), submitted by Instrumed International, Inc. (Schaumburg, US). The FDA issued a Cleared decision on August 31, 2010, 189 days after receiving the submission on February 23, 2010. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4475.

Submission Details

510(k) Number K100518 FDA.gov
FDA Decision Cleared SESE
Date Received February 23, 2010
Decision Date August 31, 2010
Days to Decision 189 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DWP — Dilator, Vessel, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4475

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