(475 days)
The Balloon Angiographic catheter is indicated for use in right heart catheterization for cardiac angiography, and measurement of the right heart and pulmonary artery pressures. It can be used to inject radiopaque media and measure pressures in any chamber or vessel that can be entered from the right heart.
Harmac Balloon Angiographic Catheter
This document is a 510(k) clearance letter from the FDA for a medical device (Harmac Balloon Angiographic Catheter). It does not contain any information about acceptance criteria, device performance reporting, or a study that proves the device meets acceptance criteria.
The letter explicitly states that the FDA has reviewed the Section 510(k) notification of intent to market the device and determined it is "substantially equivalent" to devices marketed prior to May 28, 1976. This is a regulatory pathway for medical devices that are similar to existing legally marketed devices, and often does not require new clinical studies demonstrating safety and effectiveness compared to devices undergoing a Premarket Approval (PMA) pathway.
Therefore, I cannot extract the requested information from the provided text. The document is solely a regulatory clearance for market entry based on substantial equivalence, not a performance study report.
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Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services (HHS) in the USA. The seal is circular and features the department's name around the perimeter. In the center is an emblem of a stylized bird, possibly an eagle, with its wings spread upward. The bird is a simple, black silhouette.
OCT 16 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Michael Guzzo Quality Assurance Engineer Harmac Medical Products, Inc. 2201 Bailey Avenue Buffalo, New York 14211-1797
Re: K962829 Harmac Balloon Angiographic Catheter Regulatory Class: II (two) Product Code: DOO Dated: August 22, 1997 Received: August 29, 1997
Dear Mr. Guzzo:
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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 requlations.
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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 regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other qeneral 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.qov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(K) Number: K962829
Device Name: Harmac Balloon Angiographic Catheter
Indications for Use:
"The Balloon Angiographic catheter is indicated for use in right heart catheterization for cardiac angiography, and measurement of the right heart and pulmonary artery pressures. It can be used to inject radiopaque media and measure pressures in any chamber or vessel that can be entered from the right heart."
Contraindications:
"This device is not designed, sold, or intended for use except as indicated."
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation
| Division Sign-On | Tara A. Ryp |
|---|---|
| Division of | ratory, |
| ari Neurologia | |
| 510(k) Number | K962829 |
| Prescription Use | OR | Over-The-Counter Use | |
|---|---|---|---|
| (Per 21 CFR 801.109) |
Harmac Medical Products, Inc. K962829 Attachment 4
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).