VERSA-CATH ARTERIAL CATHETER

K961883 · Ideas For Medicine, Inc. · DXE · Jan 13, 1997 · Cardiovascular

Device Facts

• Record ID: K961883
• Device Name: VERSA-CATH ARTERIAL CATHETER
• Applicant: Ideas For Medicine, Inc.
• Product Code: DXE · Cardiovascular
• Decision Date: Jan 13, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The catheters are primarily intended for use in the removal of arterial emboli and thrombi during embolectomy and thrombectomy. The dual lumen design allows for a more versatile catheter. It can be used for injection of contrast media or heparinized saline, and/or irrigation and aspiration. The balloon when inflated can be used for vessel occlusion. Finally, it can be used for catheter placement over a guidewire.

Device Story

Versa-Cath Arterial Catheter; dual lumen nylon tube with distal natural latex balloon; proximal stopcocks for balloon inflation and fluid irrigation/aspiration. Used by physicians in clinical settings for embolectomy and thrombectomy. Procedure: catheter advanced beyond obstruction; balloon inflated with sterile solution; catheter withdrawn to extract embolism. Dual lumen enables contrast media injection, heparinized saline delivery, vessel occlusion, and guidewire-assisted placement. Packaged with syringe and stylet.

Clinical Evidence

Bench testing only; materials certified to USP Class VI standards; suture certified to USP grade; device supplied sterile and non-pyrogenic.

Technological Characteristics

Dual lumen nylon tube; natural latex balloon; proximal stopcocks; 5 sizes, 3 lengths. Materials meet USP Class VI requirements; suture is USP grade. Sterile, non-pyrogenic. Mechanical operation via manual inflation/withdrawal.

Indications for Use

Indicated for patients requiring removal of arterial emboli and thrombi, vessel irrigation, aspiration, occlusion, perfusion, and catheter placement via guidewire.

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.

Predicate Devices

• Fogarty Thru-Lumen catheter
• Robicsek Angiography catheter

Reference Devices

• Stylet (K832023)

Submission Summary (Full Text)

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K961883
Ideas for Medicine, Inc.
Versa-Cath Arterial Catheter
510(k) Notification
K961883
JAN 13 1997

# SAFETY and EFFECTIVENESS SUMMARY

## PROPRIETARY NAME:

Versa-Cath Arterial Catheter

## COMMON USUAL NAME:

Embolectomy Catheter

## CLASSIFICATION:

Class II

## CLASSIFICATION NUMBER:

74 DXE

## DEVICE DESCRIPTION:

### DESCRIPTION:

The Versa-Cath Arterial Catheter is a dual lumen nylon tube with a natural latex balloon attached to a distal end. There are two stopcocks affixed to the proximal end, one for balloon inflation and the other for fluid irrigation and/or aspiration. It will be packaged with a syringe and a stylet. The syringe is a pre-amendment device and the stylet is marketed under 510(k) K832023. The catheter will be available in 5 sizes and 3 lengths.

The catheters are primarily intended for use in the removal of arterial emboli and thrombi during embolectomy and thrombectomy.

The catheter with the balloon deflated is advanced into the vessel and advanced beyond the obstruction. The balloon is inflated with sterile solution. The catheter is withdrawn pulling the embolism with it, thus removing it from the artery. The dual lumen design allows for a more versatile catheter. It can be used for injection of contrast media or heparinized saline, and/or irrigation and aspiration. The balloon when inflated can be used for vessel occlusion. Finally, it can be used for catheter placement over a guidewire.

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Ideas for Medicine, Inc.
Versa-Cath Arterial Catheter
510(k) Notification
K961883

The materials used on the Versa-Cath Arterial Catheters have been used for years on other models of Ideas for Medicine, Inc. catheters except the suture, which has been certified to USP grade. Other catheter materials have been certified to meet the requirements of USP Class VI tests. Every lot is supplied sterile and non-pyrogenic.

## SUBSTANTIAL EQUIVALENCE:

The intended use of these devices is to remove arterial emboli and thrombi, vessel irrigation, aspiration and occlusion, perfusion and catheter placement using a guidewire. Both the Fogarty Thru-Lumen and Robicsek Angiography catheters have the same intended use.