LATIS GRAFT CLEANING CATHETER

K973465 · Applied Medical Resources · DXE · Feb 19, 1998 · Cardiovascular

Device Facts

• Record ID: K973465
• Device Name: LATIS GRAFT CLEANING CATHETER
• Applicant: Applied Medical Resources
• Product Code: DXE · Cardiovascular
• Decision Date: Feb 19, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Applied Medical latis™ Dual Lumen Graft Cleaning Catheter is a disposable catheter intended for use in the removal of thrombus from vascular grafts and for occlusion and infusion of fluids into a graft.

Device Story

The Applied Medical latis™ Dual Lumen Graft Cleaning Catheter is a single-use, disposable device designed for the removal of thromboemboli from vascular grafts. It also facilitates graft occlusion and fluid infusion. The device is operated by clinicians in a clinical setting. It functions as a mechanical tool for clearing vascular obstructions. No complex electronic or software components are involved in its operation.

Clinical Evidence

Bench testing only; mechanical safety and biocompatibility testing performed to verify functional safety, structural integrity, and material safety.

Technological Characteristics

Single-use, disposable dual-lumen catheter. Mechanical device for thrombus removal, occlusion, and fluid infusion. No electronic, software, or energy-based components.

Indications for Use

Indicated for removal of thrombus from vascular grafts and for occlusion and infusion of fluids into a graft in patients requiring vascular graft maintenance.

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

• K910372
• K950586
• K970762

Submission Summary (Full Text)

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K413465

## APPENDIX VIII

## 510(k) SUMMARY

FEB 1 9 1998

510(k) NUMBER:

PENDING

SUBMITTED BY:

Applied Medical Resources Corporation 26051 Merit Circle, #103 Laguna Hills, California 92653 [phone] EXT. 326

Mary Jo Stegwell CONTACT PERSON:

DATE OF PREPARATION: September 10, 1997

Dual Lumen Graft Cleaning Catheter NAME OF DEVICE:

Embolectomy Catheter CLASSIFICATION NAME:

Applied Medical latis™ Dual Lumen Graft Cleaning Catheter TRADE NAME:

SUMMARY STATEMENT:

The Applied Medical Dual Lumen Graft Cleaning Catheter is a single-use catheter intended for removal of thromboemboli from vascular grafts.

Mechanical safety and biocompatibility tests were performed to verify functional safety, structural integrity and material safety. All testing demonstrated that the Applied Medical Graft Cleaning Catheter is comparable to the predicate devices (K910372, K950586, K970762) and introduces no new safety and effectiveness issues when used as indicated.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 9 1998

Ms. Mary Jo Stegwell Vice President, Regulatory Affairs Applied Medical Resources 26051 Merit Circle, #104 Laguana Hills, CA 92653

Re : K973465 Applied Medical latis™ Dual Lumen Graft Cleaning Catheter Requlatory Class: II (Two) Product Code: DXE Dated: November 20, 1997 November 21, 1997 Received:

Dear Ms. Stegwell:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. . . . . . . . . . . . . . .

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Page 2 - Ms. Mary Jo Steqwell

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."

Sincerely yours,
Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): K973465

Device Name: _ Applied Medical latis™ Dual Lumen Graft Cleaning Catheter

Indications For Use: The Applied Medical latis™ Dual Lumen Graft Cleaning Catheter is a disposable catheter intended for use in the removal of thrombus from vascular grafts and for occlusion and infusion of fluids into a graft.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Bera R. Bimpere

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K973465

Prescription Use_V (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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