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
Indications for 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
(317) 463-7537
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.
