NEEDLE'S EYE SNARE

K961992 · Cook Pacemaker Corp. · DXE · Dec 27, 1996 · Cardiovascular

Device Facts

• Record ID: K961992
• Device Name: NEEDLE'S EYE SNARE
• Applicant: Cook Pacemaker Corp.
• Product Code: DXE · Cardiovascular
• Decision Date: Dec 27, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Needle's Eye Snare is intended for use in the percutaneous removal of indwelling catheters, cardiac leads, fragments and foreign objects.

Device Story

Percutaneous retrieval device for indwelling catheters, cardiac leads, fragments, and foreign objects; used in clinical settings by physicians; sterile, single-use; operation involves percutaneous insertion to capture and remove foreign bodies; biocompatible materials consistent with established medical device history; output is physical removal of object.

Clinical Evidence

No clinical data; biocompatibility supported by established history of use in medical devices.

Technological Characteristics

Intravascular retrieval snare; sterile, single-use; materials possess established history of use in medical devices; manufactured under specified process controls and quality assurance program.

Indications for Use

Indicated for percutaneous removal of indwelling catheters, cardiac leads, fragments, and foreign objects from the vasculature.

Regulatory Classification

Identification

An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.

Submission Summary (Full Text)

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K961992
510(k) Premarket Notification
Needle's Eye Snare
11
DEC 27 1996

I. 510(K) SUMMARY

Submitted By:
Neal E. Fearnot, President
MED Institute, Incorporated
P.O. Box 2402
West Lafayette, IN 47906
[phone]
May 16, 1996

Device:
Trade Name: Needle's Eye Snare
Common/Usual Name: Snare, Retrieval Basket, Basket Introducer
Proposed Classification Name: Embolectomy Catheter 21 CFR Part 870.5150 (74DXE)

Predicate Devices:
The Needle's Eye Snare is similar to predicate devices which are used for the intravascular retrieval of foreign bodies, and is also of similar technology in terms of material composition and method of operation.

Device Description:
The Needle's Eye Snare is intended for use in the percutaneous removal of indwelling catheters, cardiac leads, fragments and foreign objects. The device is supplied sterile and is intended for one-time use. Reasonable assurance of biocompatibility of the materials comprising the Needle's Eye Snare is provided by their established history of use in medical devices manufactured by the Cook Pacemaker Corporation.

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.