VESSEL DILATOR

K963388 · Maxxim Medical · DRE · Mar 11, 1997 · Cardiovascular

Device Facts

• Record ID: K963388
• Device Name: VESSEL DILATOR
• Applicant: Maxxim Medical
• Product Code: DRE · Cardiovascular
• Decision Date: Mar 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1310
• Device Class: Class 2

Indications for Use

To enlarge the opening in a vessel in preparation of percutaneous entry of a catheter.

Device Story

Vessel dilator used over guide wire to enlarge vessel opening for percutaneous catheter entry; used independently or with sheath introducer. Device comprises plastic hub with female luer lock and thermally tapered plastic cannula. Available in 4F-15F sizes. Supplied sterile/disposable or as component in kits/trays. Used by clinicians in clinical settings to facilitate vascular access; improves procedural efficiency by preparing vessel site for catheter insertion.

Clinical Evidence

Bench testing only. Biocompatibility established via cytotoxicity, intracutaneous reactivity, sensitization, acute systemic toxicity, and hemocompatibility testing. Meets USP XXIII physicochemical requirements for plastics. Tensile strength testing performed.

Technological Characteristics

Plastic hub and cannula; distal end thermally tapered. Sizes 4F-15F. Female luer lock. Biocompatibility per USP XXIII. Sterilization via standard methods for disposable medical devices.

Indications for Use

Indicated for patients requiring percutaneous catheterization where vessel dilation is necessary to facilitate entry.

Regulatory Classification

Identification

A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.

Predicate Devices

• Vessel Dilator component of Introducer for PTCA Guiding Catheters (K891022)

Submission Summary (Full Text)

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K963388
MAR 11 1997

# 510(k) SUMMARY

## I. ADMINISTRATIVE

Submitter: Maxxim Medical, Inc, Argon Division
1445 Flat Creek Road
Athens, TX 75751
[phone]

Contact Person: Eddie Monroe

Date of Preparation: August 26, 1996

## II. DEVICE NAME

Proprietary Name: None

Common Name: Vessel Dilator

Classification Name: Vessel Dilator for percutaneous catheterization

## III. PREDICATE DEVICE

Vessel Dilator component of Introducer for PTCA Guiding Catheters; K891022; Argon Medical.

## IV. DEVICE DESCRIPTION

The Vessel Dilator is a device used over a guide wire to dilate the opening in a vessel in preparation of percutaneous entry of a catheter. The device may be used separately or in conjunction with a sheath introducer. The device consists of a plastic hub attached to a plastic cannula. The distal end of the cannula is thermally tapered to assist in dilation. The hub proximal end has a female luer lock configuration. An optional hub collar may be used to attach the dilator to an introducer. The device is available in sizes 4F through 15F and is supplied as a sterile, disposable single put up in sealed pouches, in non-sterile bulk quantities, or included as a component in catheter introducer kits, trays, or packs.

Biocompatibility of the device has been established by cytotoxicity, intracutaneous reactivity, sensitization, acute systemic toxicity and hemocompatibility tests. The device meets the requirements of the USP XXIII physicochemical tests for plastics.

## V. INTENDED USE

To enlarge the opening in a vessel in preparation of percutaneous entry of a catheter.

Premarket Notification. Vessel Dilator
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Premarket Notification. Vessel Dilator

VI. COMPARISON TO PREDICATE DEVICE

The Vessel Dilator is identical in design, function and intended use, and similar in composition, to the Vessel Dilator component of the Introducer for PTCA Guiding Catheters (Argon Medical; K891022). Results of performance testing indicate that the Vessel Dilator has improved tensile strength characteristics compared to the predicate device.

Accordingly, Maxxim Medical, Inc., Argon Division, concluded that the Vessel Dilator is safe and effective for its intended use and performs at least as well as the legally marketed predicate device.