SCANLAN HEIFETZ ANEURYSM ELGILOY CLIP SYSTEM

K960372 · Scanlan Intl., Inc. · HCH · Apr 26, 1996 · Neurology

Device Facts

• Record ID: K960372
• Device Name: SCANLAN HEIFETZ ANEURYSM ELGILOY CLIP SYSTEM
• Applicant: Scanlan Intl., Inc.
• Product Code: HCH · Neurology
• Decision Date: Apr 26, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SCANLAN® Heifetz Aneurysm Elgiloy® Clip System provides standard clips and appliers used to occlude an intracranial aneurysm to prevent it from bleeding or bursting

Device Story

System consists of aneurysm clips and appliers; used to occlude intracranial aneurysms; prevents bleeding or bursting. Operated by neurosurgeons in OR setting. Clips applied to aneurysm neck to isolate sac from blood flow. Device provided non-sterile; requires sterilization before use.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material comparison to predicate.

Technological Characteristics

Materials: Elgiloy alloy. Components: Aneurysm clips and manual appliers. Form factor: Various sizes and shapes for intracranial application. Non-sterile; requires user sterilization.

Indications for Use

Indicated for occlusion of intracranial aneurysms to prevent bleeding or rupture in patients requiring neurosurgical intervention.

Regulatory Classification

Identification

An aneurysm clip is a device used to occlude an intracranial aneurysm (a balloonlike sac formed on a blood vessel) to prevent it from bleeding or bursting.

Predicate Devices

• Weck Heifetz Aneurysm Clip & Applier System (K790413)

Submission Summary (Full Text)

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K960372

# 510(k) Summary

## SUBMITTER:

Submitted on behalf of:

SCANLAN® International
One Scanlan Plaza
St. Paul, MN 55107
Telephone: [phone]

Official Correspondent:
Ken Blake
Vice President Research & Development

DATE SUMMARY PREPARED: 1-22-96

TRADE NAME: SCANLAN® Heifetz Aneurysm Elgiloy® Clip System

COMMON NAME: Aneurysm Clip & Applier System

SUBSTANTIALLY EQUIVALENT TO: Weck Heifetz Aneurysm Clip & Applier System

DESCRIPTION of the DEVICE:

The SCANLAN® Heifetz Aneurysm Elgiloy® Clip System is a device used to occlude an intracranial aneurysm (a balloonlike sac formed on a blood vessel) to prevent bleeding or bursting.) The SCANLAN® Heifetz Aneurysm Elgiloy® Clip System is sold non-sterile. Descriptions of each clip size and shape are provided in the brochure. Appliers are available in five sizes and are described in the accompanying brochure (See Appendix A.) A schematic for a representative clip size is provided in Appendix B.

## INDICATIONS FOR USE:

SCANLAN® Heifetz Aneurysm Elgiloy® Clip System provides standard clips and appliers used to occlude an intracranial aneurysm to prevent it from bleeding or bursting

## CLINICAL INFORMATION and SAFETY and EFFECTIVENESS:

SCANLAN® Heifetz Aneurysm Elgiloy® Clip System is substantially equivalent to the Weck Heifetz Aneurysm Clip system (clips and appliers) that are represented in part by K790413. Note that the Weck system (additional clip sizes and shapes) is also a pre-amendment device. There are no substantial differences in materials, designs or performance, in so far as can be determined, between the Weck brand of Heifetz Aneurysm clips and appliers and the Scanlan International products

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