MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING

K953647 · Meadox Medicals, Div. Boston Scientific Corp. · LIT · May 16, 1997 · Cardiovascular

Device Facts

• Record ID: K953647
• Device Name: MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING
• Applicant: Meadox Medicals, Div. Boston Scientific Corp.
• Product Code: LIT · Cardiovascular
• Decision Date: May 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indications for use have not changed, and are equivalent to those of the predicate devices cited above.

Device Story

Balloon dilatation catheter; Gruntzig-style design; polymeric balloon on double-lumen shaft; Y-connector with dual female luer fittings for guidewire passage and balloon inflation; features HYDROPASS™ hydrophilic coating on balloon, tip, and distal shaft. Used by interventional cardiologists in clinical settings for vessel dilation. Coating reduces friction during navigation through vasculature. Device performance specifications, including burst pressure, remain consistent with predicate models.

Clinical Evidence

Bench testing only. Biocompatibility testing conducted in accordance with ISO-10993 standards. Performance testing confirms device meets established specifications for burst pressure and mechanical integrity.

Technological Characteristics

Polymeric balloon; double-lumen shaft; Y-connector; HYDROPASS™ hydrophilic coating applied to balloon, tip, and distal shaft. Biocompatibility per ISO-10993. Performance specifications include Mean/Average Burst Pressure.

Indications for Use

Indicated for percutaneous transluminal coronary angioplasty (PTCA) to improve myocardial perfusion in patients with coronary artery disease.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• MS CLASSIQUE™ Balloon Dilatation Catheter (K942293)
• MS CLASSIQUE™ Balloon Dilatation Catheter (K943298)

Submission Summary (Full Text)

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K953647
MAY 16 1997

# 510(k) Summary of Safety & Effectiveness

## GENERAL INFORMATION:

**Sponsor:** Meadow Medicals, Inc.
112 Bauer Drive
Oakland, NJ 07436

**Contact Person:** Stephen B Anderson

**Submission Date:** August 03, 1995

## DEVICE INFORMATION:

**Generic Name:** Balloon Dilatation Catheter

**Trade Name:** MS CLASSIQUE™ Balloon Dilatation Catheter w/HYDROPASS™ Hydrophilic Coating

**Classification Name:** Cardiovascular - Percutaneous Catheter

## PREDICATE DEVICE INFO:

The following devices, to which substantial equivalence is claimed, serve as predicate devices for this premarket notification submission:

| K# | Proprietary Name | S & C Date |
| --- | --- | --- |
| K942293 | MS CLASSIQUE™ Balloon Dilatation Catheter | 10/18/94 |
| K943298 | MS CLASSIQUE™ Balloon Dilatation Catheter | 09/08/94 |

## DEVICE DESCRIPTION:

The MS CLASSIQUE™ Balloon Dilatation Catheter with HYDROPASS™ Hydrophilic Coating is a polymeric balloon mounted on a double lumen shaft, a design commonly referred to as a “Gruntzig style catheter”. Proximally the product is fitted with a Y-connector system with two female luer fittings, one for passage of a guide wire, and the other for balloon inflation. The product is coated with Meadow’s exclusive hydrophilic coating on the balloon, the tip and distal shaft.

## BIOCOMPATIBILITY:

Biocompatibility testing, conducted in accordance with the ISO-10993 standard, indicates that the MS CLASSIQUE™ Balloon Dilatation Catheter with HYDROPASS™ Hydrophilic Coating is safe for it’s labeled indications.

## INDICATIONS:

Indications for use have not changed, and are equivalent to those of the predicate devices cited above.

## DESIGN MATERIALS:

Design materials have not changed, and are equivalent to those of the predicate devices cited above.

## MANUFACTURING:

The manufacturing process now has an additional production step during which HYDROPASS™ Hydrophilic Coating is applied to the catheter.

## SPECIFICATIONS:

The package labeling of the MS CLASSIQUE™ Balloon Dilatation Catheter will now specify Mean or Average Burst Pressure. All MS CLASSIQUE™ Balloon Dilatation Catheters with HYDROPASS™ Hydrophilic Coating meet currently established performance specifications for uncoated MS CLASSIQUE™ Balloon Dilatation Catheters.

## CONCLUSION:

The addition of HYDROPASS™ Hydrophilic Coating to MS CLASSIQUE™ Balloon Dilatation Catheters does not alter the level of safety and effectiveness associated with the currently marketed products.

MS CLASSIQUE™ is a trademark of Meadow Surgined A/S.
HYDROPASS™ is a trademark of Meadow Medicals, Inc.
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