CES VASCULAR OCCLUSION SYSTEM

K964367 · Cordis Neurovascular, Inc. · HCG · Jan 30, 1997 · Neurology

Device Facts

• Record ID: K964367
• Device Name: CES VASCULAR OCCLUSION SYSTEM
• Applicant: Cordis Neurovascular, Inc.
• Product Code: HCG · Neurology
• Decision Date: Jan 30, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

CES Occlusion Devices may be used to reduce or block the rate of blood flow in small or tapering vessels. They are indicated for use in the interventional radiologic management of arteriovenous malformations and other vascular lesions of the brain, spinal cord and spine when devascularization prior to definitive surgical resection is desired.

Device Story

CES Vascular Occlusion System consists of occlusion coils and coil pusher; used to reduce/block blood flow in small/tapering vessels. Operated by interventional radiologists; deployed via catheter into target vasculature (brain, spinal cord, spine). Coils provide mechanical occlusion to devascularize lesions prior to surgical resection. System design and function analogous to existing embolic coil technologies.

Clinical Evidence

Bench testing only; biocompatibility testing successfully performed on occlusion device and coil pusher.

Technological Characteristics

System includes occlusion coils and coil pusher. Materials biocompatibility verified. Mechanical occlusion principle. No software or electronic components.

Indications for Use

Indicated for patients requiring reduction or blockage of blood flow in small or tapering vessels, specifically for interventional radiologic management of arteriovenous malformations and vascular lesions of the brain, spinal cord, and spine prior to surgical resection.

Regulatory Classification

Identification

A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.

Special Controls

*Classification.* Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).

Predicate Devices

• Target Therapeutics Fibered Helical Coils (K901721)
• Cook, Inc. Hilal Embolization Microcoil (K901337)
• Target Therapeutics Helical Coils and Coil Pusher (K891688)
• Cordis Endovascular Systems (CES), Inc. Instinct® Steerable Guidewire (K930982)

Submission Summary (Full Text)

{0}

01/30/97 16:58 3058248610 CES 002
K964367
JAN 30 1997

# PREMARKET NOTIFICATION 510(k)
## Cordis Corporation
### CES Vascular Occlusion System

# SUMMARY OF SAFETY AND EFFECTIVENESS

## I. General Provisions

**Common or Usual Name:** Occlusion Device or Occlusion Coils or Fibered Microcoils Coil pusher or Embolic Coil Pusher

**Proprietary Name:** CES Vascular Occlusion System

## II. Name of Predicate Devices

- Target Therapeutics Fibered Helical Coils (K901721 - concurred 07/03/90)
- Cook, Inc. Hilal Embolization Microcoil (K901337 - concurred 11/09/90)
- Target Therapeutics Helical Coils and Coil Pusher (K891688 - concurred 09/15/89)
- Cordis Endovascular Systems (CES), Inc. Instinct® Steerable Guidewire (K930982 - concurred 02/24/94)

## III. Classification

Class III

## IV. Performance Standards

Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act.

## V. Intended Use and Device Description

CES Occlusion Devices may be used to reduce or block the rate of blood flow in small or tapering vessels. They are indicated for use in the interventional radiologic management of arteriovenous malformations and other vascular lesions of the brain, spinal cord and spine when devascularization prior to definitive surgical resection is desired.

## VI. Biocompatibility

All appropriate biocompatibility tests were successfully performed on the CES Occlusion System (occlusion device and coil pusher).

## VII. Summary of Substantial Equivalence

The CES Vascular Occlusion System (occlusion device and coil pusher) are similar in their basic design, construction, indication for use and performance characteristics to other commercially available coil occlusion systems.