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K Number
K981441
Device Name
HEART CATH TRAY, STERILE, DISPOSABLE
Manufacturer
TRINITY LABORATORIES, INC.
Date Cleared
1998-07-10

(80 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

Trinity's Heart Cath Tray is a sterile prepackaged disposable unit. It contains the non-reinforced gowns, femoral angio drape, OR cloth towels, absorbent towels, 16 oz sponge bowl, 32 oz sponge bowls, bowl guidewire with lid, 2 oz medicine cups, gauze sponges, straight mosquito forceps, 25 ga x 5/8" needle, 22 ga x 1 1/2" needle, 5cc L/L syringe, 10cc L/L syringe, 20cc L/L syringe, 10cc L/S syringes, towel clips, #11 blade scalpel, table cover, and band bag, neccessary for the performance of the Heart Cath surgical procedure..

Device Description

Trinity's Heart Cath Tray is a sterile prepackaged disposable unit. It contains the non-reinforced gowns, femoral angio drape, OR cloth towels, absorbent towels, 16 oz sponge bowl, 32 oz sponge bowls, bowl guidewire with lid, 2 oz medicine cups, gauze sponges, straight mosquito forceps, 25 ga x 5/8" needle, 22 ga x 1 1/2" needle, 5cc L/L syringe, 10cc L/L syringe, 20cc L/L syringe, 10cc L/S syringes, towel clips, #11 blade scalpel, table cover, and band bag, neccessary for the performance of the Heart Cath surgical procedure..

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called "Heart Cath Tray". It is not a study report or a technical document describing acceptance criteria and device performance. Therefore, I cannot extract the requested information.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, which means its safety and effectiveness are considered to be similar to devices already on the market. However, it does not provide details of specific performance criteria or the results of a study to demonstrate those criteria.

To answer your questions, I would need a technical report, a clinical study summary, or a comprehensive PMA/510(k) submission that details the performance data and acceptance criteria for the device.

§ 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).