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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
SU
Reference & Predicate Devices
N/A
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.

N/A