ACS VIKING GUIDING CATHETER

K972484 · Guidant Corp. · DQY · Sep 26, 1997 · Cardiovascular

Device Facts

• Record ID: K972484
• Device Name: ACS VIKING GUIDING CATHETER
• Applicant: Guidant Corp.
• Product Code: DQY · Cardiovascular
• Decision Date: Sep 26, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The ACS VIKING™ Guiding Catheter is intended to provide a pathway through which therapeutic and diagnostic devices are introduced.

Device Story

ACS VIKING™ Guiding Catheter functions as a conduit for delivering therapeutic and diagnostic devices to target cardiovascular sites. Device features a radiopaque shaft with variable distal stiffness, a radiopaque soft tip, and optional side holes. Available in five diameters and lengths ranging from 40 to 160 cm (standard 100 cm). Used by clinicians in cardiovascular procedures to facilitate device navigation. Provides a stable pathway for interventional tools, aiding in successful delivery of therapies to the patient.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Radiopaque shaft with variable distal stiffness; radiopaque soft tip; available with or without side holes. Lengths 40-160 cm. Biocompatible materials. Mechanical device; no software or energy source.

Indications for Use

Indicated for use as a pathway for the introduction of therapeutic and diagnostic devices in patients requiring cardiovascular intervention.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• ACS TOURGUIDE™ Coronary Guiding Catheter (K953987)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows a sequence of alphanumeric characters, seemingly handwritten. The sequence appears to be 'K072424', with some characters slightly distorted or stylized. The characters are written in a dark color, contrasting with the lighter background.

SEP 2 6

## 510(k) Summary ACS VIKING™ Guiding Catheter

- 1. Device Name: ACS VIKING™ Guiding Catheter
- 2. Devices to which Equivalence is Claimed: ACS TOURGUIDE™ Coronary Guiding Catheter (K953987)
- 3. Indication: The ACS VIKING™ Guiding Catheter is intended to provide a pathway through which therapeutic and diagnostic devices are introduced.
- 4. Device Description: The ACS VIKING™ Guiding Catheter is available in five diameters. The catheter has a standard length of 100 cm, but can be produced in lengths from 40 to 160 cm. The ACS VIKING™ Guiding Catheter is available in varying tip shapes. The guiding catheter has a radiopaque shaft, which varies in stiffness at the distal end. The catheter has a radiopaque soft tip and is available with or without side holes.
- 5. Summary of Substantial Equivalence: The indications, methods and conditions of use, packaging process and location, sterilization process and location, and bench test results of the subject device are identical to those of the currently marketed ACS TOURGUIDE™ Coronary Guiding Catheter (K953987). Moreover, the two catheters are similar in design and are composed of materials which have undergone biocompatibility testing showing acceptability for clinical use.
- 6. Conclusion: The ACS VIKING™ Guiding Catheter is substantially equivalent to the currently marketed ACS TOURGUIDE™ Coronary Guiding Catheter (K953987).

{1}------------------------------------------------

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure with three overlapping profiles, representing the department's focus on health and human well-being. The logo is simple and recognizable, conveying the department's mission and purpose.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 6 1997

Mr. Judith P. Palin Guidant Corporation Advanced Cardiovascular Systems 3200 Lakeside Drive P.O. Box 58167 Santa Clara, California 95052-8167

Re: K972484 ACS VIKING™ Guiding Catheter Requlatory Class: II (two) Product Code: 74 DQY Dated: July 1, 1997 Received: July 2, 1997

Dear Ms. Palin:

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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, 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 regulation 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.

{2}------------------------------------------------

Page 2 - Ms. Judith P. Palin

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 requlation (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. Callahon

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

Enclosure

{3}------------------------------------------------

Page

510(k) Number (if known): K972484

Device Name: ACS VIKING Tm Guiding Catheter

Indications For Use: The ACS VIKING TH Guiding Catheter is intended to provide a pathway through which therapeutic and diagnostic devices are introduced.

Th AR.

(Division Sign-Off): Division or Cardiovascular, Respiratory, ang Maga Pogical De 51 . . . Mumber

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) \$\checkmark\$

CR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

一、

l