FLEXIBLE DILATING SHEATH

K945586 · Med Institute, Inc. · DRE · Apr 4, 1997 · Cardiovascular

Device Facts

• Record ID: K945586
• Device Name: FLEXIBLE DILATING SHEATH
• Applicant: Med Institute, Inc.
• Product Code: DRE · Cardiovascular
• Decision Date: Apr 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1310
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Flexible Dilating Sheath is intended for percutaneous dilation of tissue surrounding indwelling catheters or foreign objects.

Device Story

Flexible Dilating Sheath; used for percutaneous dilation of tissue around indwelling catheters or foreign objects; supplied sterile; single-use; manufactured via established process controls and quality assurance programs; biocompatible materials.

Clinical Evidence

Bench testing only; biocompatibility testing performed with results meeting requirements.

Technological Characteristics

Flexible sheath design; biocompatible materials with established history of use; supplied sterile for single-use; manufactured under specified process controls.

Indications for Use

Indicated for percutaneous dilation of tissue surrounding indwelling catheters or foreign objects in patients requiring such procedures.

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

• Cook Pacemaker Corporation dilating sheaths

Submission Summary (Full Text)

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510(k) Premarket Notification
Flexible Dilating Sheath
K945586
8

I. 510 (K) SUMMARY

Submitted By:
Neal E. Fearnot
President
MED Institute, Incorporated
P.O. Box 2402
West Lafayette, IN 47906
[phone]
November 11, 1994

Device:
Trade Name: Flexible Dilating Sheath
Common/Usual Name: Vessel Dilator, Catheter Dilator
Proposed Classification: Vessel Dilator for Percutaneous Catheterization
21 CFR Part 870.1310 (74DRE)

Predicate Devices:
The Flexible Dilating Sheath is similar to predicate dilating sheaths manufactured by Cook Pacemaker Corporation.

Device Description:
The Flexible Dilating Sheath is intended for percutaneous dilation of tissue surrounding indwelling catheters or foreign objects. The device is supplied sterile and is intended for one-time use. Reasonable assurance of biocompatibility of the materials comprising the Flexible Dilating Sheath is provided by their established history of use in medical product manufacturing. Results of toxicity testing also provide reasonable assurance of biocompatibility, with the results showing the material to meet the test requirements.

Substantial Equivalence:
The device will be manufactured according to specified process controls and a Quality Assurance Program, undergoing packaging and sterilization procedures similar to devices currently marketed and distributed by Cook Pacemaker Corporation. This device is similar with respect to indications for use, materials and physical construction to predicate devices in terms of section 510(k) substantial equivalency.