Cleared Traditional

SMART SET

K972663 · Top Spins, Inc. · General Hospital
Sep 1997
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K972663 is an FDA 510(k) clearance for the SMART SET, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Top Spins, Inc. (Plymouth, US). The FDA issued a Cleared decision on September 2, 1997, 56 days after receiving the submission on July 8, 1997. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K972663 FDA.gov
FDA Decision Cleared SESE
Date Received July 08, 1997
Decision Date September 02, 1997
Days to Decision 56 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code FPA — Set, Administration, Intravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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