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K Number
K110903
Device Name
PTS-X SIZING BALLOON CATHETER
Manufacturer
NUMED, INC.
Date Cleared
2011-04-29

(29 days)

Product Code
MJN
Regulation Number
870.4450
Type
Special
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Recommended for use in those patients with cardiovascular defects wherein accurate measurement of the defect is important to select the appropriately sized occluder device.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for the PTS-X Sizing Balloon Catheter. It indicates that the device has been found substantially equivalent to a predicate device.

The provided text does not contain information regarding acceptance criteria, device performance from a study, sample sizes, expert qualifications, or any details about an AI algorithm. It is a regulatory approval document, not a study report.

Therefore, I cannot fulfill the request for information about acceptance criteria and a study proving device performance using the provided text.

§ 870.4450 Vascular clamp.

(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).