(28 days)
THE JOMED GUIDING CATHETER IS INTENDED FOR USE FOR INTRAVASCULAR INTRODUCTION OF INTERVENTION AL/ DEAGNOSTIC DEVICES INTO THE CORONARY OR PERIPHERAL VASCULAR SYSTEMS.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the JOGUIDE Cardiovascular Guiding Catheter. This type of document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies as typically found in a clinical study report or a detailed pre-market submission.
The letter explicitly states: "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..."
This means the device was cleared based on its substantial equivalence to a predicate device, not necessarily on a novel clinical trial demonstrating specific performance metrics. Therefore, I cannot provide the requested information from this document.
{0}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 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 an abstract symbol that resembles an eagle or a stylized human figure, composed of three parallel, curved lines.
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.
{1}------------------------------------------------
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 (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
{2}------------------------------------------------
Page 1 of 1
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-
§ 870.1250 Percutaneous catheter.
(a)
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.(b)
Classification. Class II (performance standards).