JOGUIDE CARDIOVASCULAR GUIDING C ATHETER

K021088 · Jomed Catheter, Inc. · DQY · May 2, 2002 · Cardiovascular

Device Facts

• Record ID: K021088
• Device Name: JOGUIDE CARDIOVASCULAR GUIDING C ATHETER
• Applicant: Jomed Catheter, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: May 2, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

THE JOMED GUIDING CATHETER IS INTENDED FOR USE FOR INTRAVASCULAR INTRODUCTION OF INTERVENTION AL/ DEAGNOSTIC DEVICES INTO THE CORONARY OR PERIPHERAL VASCULAR SYSTEMS.

Device Story

Joguide Cardiovascular Guiding Catheter is a percutaneous catheter used by physicians in clinical settings to facilitate the delivery of interventional or diagnostic devices into coronary or peripheral vasculature. The device acts as a conduit for other medical instruments. It is a passive mechanical device; no electronic or software components are involved. Benefit to patient includes enabling minimally invasive access to the vascular system for diagnostic or therapeutic procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Percutaneous catheter; Class II; Product Code 74 DQY. Mechanical device for vascular access. No electronic, software, or energy-based components.

Indications for Use

Indicated for intravascular introduction of interventional or diagnostic devices into the coronary or peripheral vascular systems.

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Norman Hall Manager, QA/RA JOMED Catheter, Inc. 604 Queensbury Avenue Queensbury, NY 12804

MAY 0-2 2002

Re: K021088 Joguide Cardiovascular Guiding Catheter Regulation Number: 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II (two) Product Code: 74 DQY Dated: April 1, 2002 Received: April 4, 2002

Dear Mr. Hall:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 - Mr. Norman Hall

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Nolen Tur

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510 (K) NUMBER (IF KNOWN): KOZ 1088 JOGUIDE PERCUTANEOUS (GUIDE) CATHETER DEVICE NAME: INDICATIONS FOR USE:

THE JOMED GUIDING CATHETER IS INTENDED FOR USE FOR INTRAVASCULAR INTRODUCTION OF INTERVENTION AL/ DEAGNOSTIC DEVICES INTO THE CORONARY OR PERIPHERAL VASCULAR SYSTEMS.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | X |
|----------------------|---|
| (Per 21 CFR 801.109) | |

Division of Cardiovascular & Respiratory Devices
510(k) Number K021088OR

Over - The - Counter - Use (Optional Format 1-