MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR

• K Number: K990514
• Device Name: MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR
• Manufacturer: C.R. BARD, INC.
• Date Cleared: 1999-03-09 ( 19 days)
• Product Code: DTP
• Regulation Number: 870.4230
• Type: Special
• Panel: CV
• Reference & Predicate Devices: N/A

Intended Use

The Bard Quantum CVR is designed to function in an extracorporeal circuit. The filtered cardiotomy/reservoir receives dynamic blood from: 1) Venous return; 2) Intracardiac suction; 3) Ventricular vent devices; 4) Arterial-venous shunts. It defoams, filters and stores this blood prior to returning it to the circuit.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter for a medical device (Bard Quantum CVR) and a statement of its indications for use. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as typically found in a clinical study report or a detailed premarket submission summary.

Therefore, I cannot extract the requested information from the given input.

Regulation Number and Section

§ 870.4230 Cardiopulmonary bypass defoamer.

(a)
Identification. A cardiopulmonary bypass defoamer is a device used in conjunction with an oxygenator during cardiopulmonary bypass surgery to remove gas bubbles from the blood.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Extracorporeal Blood Circuit Defoamer 510(k) Submissions.”