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K Number
K963335
Device Name
HARMAC BALLOON WEDGE PRESSURE CATHETER
Manufacturer
HARMAC MEDICAL PRODUCTS, INC.
Date Cleared
1997-10-16

(475 days)

Product Code
DQO
Regulation Number
870.1200
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Balloon Wedge Pressure catheter is indicated for use in sampling blood for oxygen levels and measuring pressure in the right heart (including central venous pressure, right ventricular pressure, pulmonary artery pressure and pulmonary artery wedge pressure). In the case of anatomical cardiac defect or situations requiring left transseptal access, this catheter may be used in any chamber which can be entered from the right heart.

Device Description

Harmac Balloon Wedge Pressure Catheter

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device -- Harmac Balloon Wedge Pressure Catheter. It does not contain sections on acceptance criteria or performance studies. Therefore, I cannot provide the information requested.

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).