RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTRODUCER STYLET

K953945 · Dlp, Inc. · DWF · Mar 26, 1996 · Cardiovascular

Device Facts

• Record ID: K953945
• Device Name: RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTRODUCER STYLET
• Applicant: Dlp, Inc.
• Product Code: DWF · Cardiovascular
• Decision Date: Mar 26, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The cannula are intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus.

Device Story

DLP Elongated and Treaded Cuff Retrograde Coronary Sinus Perfusion (RCSP) cannula; used for retrograde delivery of cardioplegia solutions during cardiac surgery. Device consists of silicone cannula body and cuff; design features elongated and treaded cuff for secure placement. Operated by cardiac surgeons/perfusionists in clinical/OR settings. Provides conduit for cardioplegia solution flow; facilitates myocardial protection during bypass. Equivalent to predicate RCSP cannulae in function and material composition.

Clinical Evidence

No clinical data; bench testing only. Biocompatibility testing confirmed materials are acceptable.

Technological Characteristics

Silicone construction; elongated and treaded cuff design. Passive perfusion cannula. Biocompatible materials.

Indications for Use

Indicated for patients undergoing cardiac surgery requiring retrograde cardioplegia delivery via the coronary sinus.

Regulatory Classification

Identification

A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.

Predicate Devices

• DLP RCSP cannula
• Research Medical RCSP cannula
• Sarns 3M RCSP cannula

Submission Summary (Full Text)

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K 3945
MAR 26 1996

# SUMMARY OF SAFETY AND EFFECTIVENESS

1. INDICATIONS: The indications or intended use for the DLP Elongated and Treaded Cuff Retrograde Coronary Sinus Perfusion (RCSP) cannula are the same as the DLP, Research Medical and Sarns 3M marketed RCSP cannula. The cannula are intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus.

2. DESIGN: The design of the DLP Elongated and Treaded Cuff RCSP cannula is similar to predicate products. Size and shape contain minor differences. Technological characteristics are equivalent. Cuff length and texture differences do not affect flow characteristics.

3. MATERIALS: The materials used for the cuffs and cannula body are silicone which is same as that for DLP and SARNS 3M marketed RCSP devices. Materials have been tested to be biocompatibility acceptable.

4. SAFETY & EFFICACY: No difference in Safety and Efficacy. Since materials, indications and technology are the same, no new issues of Safety and Efficacy of the device are introduced.

5. DIFFERENCES: The differences are minor and nonsignificant differences.

Roger W. Brink
Director of Regulatory Affairs
DLP, Div. of Medtronic, Inc.

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