PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE

K980762 · Pall Corp. · DTM · Sep 1, 1998 · Cardiovascular

Device Facts

Record IDK980762
Device NamePALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE
ApplicantPall Corp.
Product CodeDTM · Cardiovascular
Decision DateSep 1, 1998
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 870.4260
Device ClassClass 2
AttributesTherapeutic

Intended Use

The Pall STAT-PRIMe Blood Filter for Extracorporcal Service is indicated for use in cardiopulmonary bypass procedures for the removal of microemboli in the arterial return line.

Device Story

The Pall STAT-PRIMe Blood Filter is an extracorporeal device designed for use during cardiopulmonary bypass procedures. It functions as an in-line filter placed within the arterial return line of the bypass circuit. Its primary purpose is the removal of microemboli from the blood flow before it returns to the patient. The device incorporates the Duroflo® treatment, which is applied to the filter components to enhance biocompatibility. It is intended for use by trained medical professionals, such as perfusionists or surgeons, in a clinical setting (e.g., operating room). By reducing the presence of microemboli, the device aims to mitigate the risk of embolic complications during bypass surgery.

Clinical Evidence

Bench testing only.

Technological Characteristics

Extracorporeal blood filter featuring Duroflo® treatment for biocompatibility. Designed for integration into arterial return lines of cardiopulmonary bypass circuits. Mechanical filtration principle.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass procedures requiring removal of microemboli from the arterial return line.

Regulatory Classification

Identification

A cardiopulmonary bypass arterial line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (blood clots or pieces of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. It is used in the arterial return line.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions.”

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 1 1998 SEP Robert A. Dickstein, Ph.D. Pall Corporation 2200 Northern Boulevard East Hills, NY 11548 K980762 Re : R900702 Pall Stat-Prime D Blood Filter for Extracorporeal Service (Featuring the Duroflo® Treatment) Regulatory Class: III (three) Product Code: DTM Dated: June 16, 1998 Received: June 17, 1998 Dear Dr. Dickstein: We have reviewed your Section 510(k) notification of intent to market we nave reviewed your boots. In have determined the device in the device 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 Incelstate Commende proble of to devices that have been reclassified riedrear bevice Amonomenter, of the Federal Food, Drug, and In accordance with the provisions of the market the device, subject to the general controls provisions of the Act. The general controls enc general contract 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 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. {1}------------------------------------------------ Page 2 - Robert A. Dickstein, Ph.D. 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 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, Thomas J. Callahan Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ 510(k) Number (if known): K980762 Device Name: Pall STAT. PRimie D Bloud Filter for Extracorporeal Service Indications For Use: The Pall STAT-PRIMe Blood Filter for Extracorporcal Service 15 indicated for use in cardiopulmonary bypass procedures for the removal of microemboli in the arterial return line. PAGE IF NEEDED) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A Concurrence of CDRH, Office of Device Evaluation (ODE) Bete V. Cooper De (Division Sign-Off) Iivision of Cardiovascular, Res Neurological Devices 1980 (k) Number Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96)
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