Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling: Guidance for Industry and Food and Drug Administration Staff

Description

Thisguidance documentprovides recommendations for premarket notification (510(k)) submissions for guidewires intended for use in the coronary vasculature, peripheral vasculature, and neurovasculature.  The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of these submissions. For the purposes of this guidance, the coronary vasculature includes blood vessels within the heart, including the ostium of the left main coronary artery; the neurovasculature includes blood vessels within the cranium, typically considered the vasculature distal to the cervical segment of the internal carotid artery; the peripheral vasculature includes all other cardiovascular vasculature. This document is intended to assist industry in designing and executing appropriate performance testing to support a 510(k) submission and provides recommendations for content and labeling to include in the submission.

Scope & Applicability

Regulatory Context

• 21CFR807.81§ 807.81 When a premarket notification submission is required.

  (a) Except as provided in paragraph (b) of this section, each person who is required to register his establishment pursuant to § 807.20 must submit a premarket notification submission to the Food and Drug Administration at least 90 days before he proposes to begin the introduction or delivery for inRead full regulation →

• 21CFR801.109§ 801.109 Prescription devices.

  A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which “adequate directions for use” canRead full regulation →

• 21CFR807.87§ 807.87 Information required in a premarket notification submission.

  Each premarket notification submission shall contain the following information:Read full regulation →

• 21CFR870.1330§ 870.1330 Catheter guide wire.

  (a) Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.Read full regulation →

• Clinical Investigator

  Shirish M. Gadgeel, M.D.

  2025-09-09

• Clinical Investigator

  Mark J. Savant, M.D

  2025-07-15

• Bioresearch Monitoring Program/Institutional Review Board (IRB)

  United Health Products, Inc.

  2025-05-20

• Clinical Investigator

  Americo F. Padilla, M.D.

  2025-03-25

• Institutional Review Board (IRB)

  Armstrong County Memorial Hospital

  2024-11-05

• Clinical Investigator

  Namita A. Goyal, M.D.

  2024-10-22

• Institutional Review Board (IRB)

  Louisiana State University Health Science Center IRB

  2024-10-08

• Bioresearch Monitoring Program/IRB

  Massachusetts Institute of Technology MIT

  2024-07-16

• Clinical Investigator (Sponsor)

  Angela D. Ritter, M.D.

  2024-06-18

• Institutional Review Board (IRB)

  New York State Psychiatric Institute IRB

  2024-03-26

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