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Smart Set

by Top Spins, Inc. 2 variants

510(k) K972663

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK972663 Date2 Sep 1997ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FPA
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Smart Set is a medical device designed for use with MR injectors. It increases the reliability of bolus timing and minimizes the bolus gap during the switch of gadolinium to saline flush. The tubing is specifically designed for dynamic gadolinium injections of MRA or MRI.

The device features a Swivel Lock to prevent IV separation from angiocatheter and has two inputs for simultaneous attachment of contrast and flush syringes. It includes check valves that automatically switch between functions. Smart Set is supplied as a single-use device and requires storage according to manufacturer instructions.

Other devices from Top Spins, Inc.

Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the SMART Set device?

    The SMART Set is designed for use with MR injectors to increase bolus timing reliability and minimize bolus gaps during the switch from gadolinium to saline flush during dynamic gadolinium injections for MRA or MRI procedures.

  • How is the SMART Set supplied and can it be reused?

    The SMART Set is supplied as a single-use device and should not be reused. It requires storage according to the manufacturer's instructions to maintain its integrity and functionality.

  • What are the key features of the SMART Set tubing system?

    The SMART Set features a Swivel Lock to prevent IV separation from angiocatheter and has two inputs for simultaneous attachment of contrast and flush syringes. It includes check valves that automatically switch between functions.

  • What regulatory authorization does the SMART Set have?

    The SMART Set has received FDA 510(k) clearance with K number K972663, classified under product code FPA, and was determined to be substantially equivalent through the traditional clearance pathway.