(84 days)
The Low Profile Port system is indicated whenever patient therapy requires repeated intravascular injection or continuous infusion of fluids, medications, antibiotics, nutritionals, and the withdrawal of venous blood samples.
Low Profile Plastic Port Attachable Catheter with Blue Flex Tip® System / Introducer Kit
This document is a 510(k) premarket notification approval letter from the FDA for a medical device called "Low Profile Port® Attachable Catheter with Blue Flex Tip®/8Fr. Introducer Kit Implantable Vascular Access System."
Based on the provided text, there is no information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other specific details requested in your prompt. This document only states that the device has been found substantially equivalent to predicate devices and can now be marketed.
Therefore, I cannot populate the table or answer the other questions as the information is simply not present in the provided text.
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Image /page/0/Picture/1 description: The image shows the logo for the United States Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 2 1998
Mr. Bradley J. Enegren Arrow International, Inc. 1600 Providence Highway Walpole, MA 02081
K981782 Re: Low Profile Port® Attachable Catheter with Blue Flex Tip®/8Fr. Introducer Kit Implantable Vascular Access System Regulatory Class: II (two) Product Code: 74 DYB Dated: May 18, 1998 Received: May 20, 1998
Dear Mr. Enegren:
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 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). 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 requirements, as set forth in the Quality System Requlation (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 Failure to comply with the GMP regulation may result in assumptions. 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 - Mr. Bradley J. Enegren
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 (301) 594-4648. 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 requlation 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 (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
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
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501(K) Number (if known):
Device Name:
Low Profile Plastic Port Attachable Catheter with Blue Flex Tip® System / Introducer Kit
Indications For Use:
The Low Profile Port system is indicated whenever patient therapy requires repeated intravascular injection or continuous infusion of fluids, medications, antibiotics, nutritionals, and the withdrawal of venous blood samples.
Tan A. h
(Division Sign-Off) Division of Concessoular, Respiratory, and Neuts of the reservices 510(k) Number ..
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | V |
|---|---|
| (Per 21 CFR 801.109) |
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).