K970762 · Applied Medical Resources · DXE · Mar 28, 1997 · Cardiovascular
Device Facts
Record ID
K970762
Device Name
DUAL LUMEN EMBOLECTOMY CATHETER
Applicant
Applied Medical Resources
Product Code
DXE · Cardiovascular
Decision Date
Mar 28, 1997
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 870.5150
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Applied Medical Dual-Lumen Embolectomy Catheter is a sterile disposable balloon catheter. It is indicated for the removal of arterial thromboemboli, for temporary occlusion, and for infusion of fluids. It may be used with or without a guidewire.
Device Story
Sterile, disposable dual-lumen balloon catheter; features inflation lumen, fluid infusion lumen, Y-connector, and distal latex balloon. Radiopaque marker bands located proximal and distal to balloon. Supplied with 1cc or 3cc syringe depending on model size (3F-7F). Used by surgeons in clinical settings during arteriotomy; catheter inserted into artery with or without guidewire; passed through clot; balloon inflated for clot extraction; second lumen utilized for fluid infusion. Facilitates thromboemboli removal and temporary occlusion; provides dual functionality (occlusion/infusion) in single device.
Clinical Evidence
Bench testing only. Mechanical and biocompatibility tests performed to verify functional and structural integrity and material safety.
Technological Characteristics
Dual-lumen catheter body; latex balloon; radiopaque marker bands. Sterile, disposable. Sizes 3F through 7F. Includes Y-connector and inflation/infusion ports. Manual operation.
Indications for Use
Indicated for removal of arterial thromboemboli, temporary vessel occlusion, and fluid infusion in patients requiring embolectomy procedures.
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.
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MAR 28 1997
K970762
# APPENDIX IX
## 510(k) SUMMARY
| 510(k) NUMBER: | PENDING |
| --- | --- |
| SUBMITTED BY: | Applied Medical Resources
26051 Merit Circle # 103
Laguna Hills, Ca 92653
(714) 582-6120 Ext. 310 |
| CONTACT PERSON: | Howard V. Rowe |
| DATE OF PREPARATION: | February 27, 1997 |
| NAME OF DEVICE: | Applied Medical Dual Lumen Embolectomy Catheter |
| CLASSIFICATION NAME: | Embolectomy Catheter |
## SUMMARY STATEMENT:
The Applied Medical Dual-Lumen Embolectomy Catheter is a sterile disposable balloon catheter. It is indicated for the removal of arterial thromboemboli, for temporary occlusion, and for infusion of fluids. It may be used with or without a guidewire. The catheter body features two channels through the length of its main body and includes access ports on the inflation and fluid infusion lumens, a Y connector, and a latex balloon on the distal end. Radiopaque marker bands are proximal and distal to the balloon. A 1cc syringe is supplied with the 3F, 4F and 5F models while a 3cc syringe is supplied with the 6F and 7F models.
The Applied Medical Dual-Lumen Embolectomy Catheter is used in the same manner as a conventional embolectomy catheter when only the inflation lumen is utilized. The diseased artery is exposed, clamped, and an arteriotomy is performed. The catheter is inserted into the arteriotomy with or without a guidewire and passed through the clot. The second lumen may then be used for infusion. The balloon is inflated and the clot is extracted.
The Applied Medical Dual-Lumen Embolectomy Catheter is substantially equivalent to the Fogarty® Thru-Lumen Embolectomy Catheter marketed by Baxter Healthcare Corporation. The performance of the balloon is substantially equivalent to the Applied Medical Regular Tip Embolectomy Catheter. Mechanical and biocompatibility tests were performed to verify functional and structural integrity as well as material safety.
All testing demonstrates the Applied Medical Dual-Lumen Embolectomy Catheter to be equivalent to the predicate devices and introduces no new safety and effectiveness issues when used as indicated.
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