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K Number
K092552
Device Name
CLO-SURPLUS P.A.D.
Manufacturer
SCION CARDIO-VASCULAR, INC.
Date Cleared
2009-09-04

(15 days)

Product Code
QSY,LYA
Regulation Number
N/A
Type
Traditional
Panel
General & Plastic Surgery
Reference & Predicate Devices
N/A
Predicate For
K112191,K112961,K150916
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Not Found

Device Description

Not Found

AI/ML Overview

I apologize, but the document provided is a letter from the FDA to Scion Cardio-Vascular, Inc. regarding an administrative change to a previous substantial equivalence determination. It discusses a change in product codes for the Clo-SurPLUS P.A.D. device.

This document does not contain any information about:

  • Acceptance criteria for the device
  • Device performance data
  • Details of any studies conducted (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance).

Therefore, based solely on the provided text, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them.

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Scion Cardio-Vascular, Inc. c/o Dennis Hammond Director QA/RA 14256 SW 119th Ave. Miami. Florida 33186

July 28, 2023

Re: K092552 Trade/Device Name: Clo-SurPLUS P.A.D. Regulatory Class: Unclassified Product Code: QSY, LYA

Dear Dennis Hammond:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated September 4, 2009. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product codes QSY and LYA.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-402-3839, Julie.Morabito@fda.hhs.gov.

Sincerely,

Julie A. Morabito -S

Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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