PULSE*SPRAY INFUSION SYSTEM
Device Facts
| Record ID | K951509 |
|---|---|
| Device Name | PULSE*SPRAY INFUSION SYSTEM |
| Applicant | Angiodynamics, Div. E-Z-Em, Inc. |
| Product Code | QEY · Cardiovascular |
| Decision Date | Jun 16, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.5150 |
| Device Class | Class 2 |
Device Story
Pulse*Spray Infusion System; embolectomy catheter; used for infusion of fluids/medications into vasculature; mechanical device; no electronic or software components described.
Clinical Evidence
bench testing only
Technological Characteristics
Embolectomy catheter; Class II; Product Codes QEY, KRA; mechanical infusion system.
Regulatory Classification
Identification
An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.
Submission Summary (Full Text)
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FDA
U.S. FOOD & DRUG
ADMINISTRATION
November 22, 2021
Angiodynamics
Brian Kunst
Director of RA/QA
266 Queensbury Ave.
Queensbury, New York 12804
Re: K951509
Trade/Device Name: Pulse*Spray Infusion System
Regulation Number: 21 CFR 870.5150
Regulation Name: Embolectomy catheter
Regulatory Class: Class II
Product Code: QEY, KRA
Dear Brian Kunst:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated June 16, 1995. Specifically, FDA is updating this SE Letter as an administrative correction because FDA has created a new product code to better categorize your device technology.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, (301) 796-6075, Gregory.Oconnell@FDA.HHS.gov.
Sincerely,
Gregory W.
Digitally signed by
Gregory W. O'connell -S
O'connell -S
Date: 2021.11.22
13:47:07 -05'00'
Gregory O'Connell
Assistant Director
DHT2C: Division of Coronary
and Peripheral Intervention Devices
OHT2: Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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[LOGO]
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
JUN 16 1995
Food and Drug Administration
1390 Piccard Drive
Rockville MD 20850
Mr. Brian Kunst
Director of Regulatory Affairs/
Quality Assurance
AngioDynamics™
P.O. Box 993
266 Queensbury Avenue
Glens Falls, New York 12801
Re: K951509
Pulse Spray Infusion System
Regulatory Class: II (two)
Product Code: 74 KRA
Dated: March 31, 1995
Received: April 3, 1995
Dear Mr. Kunst:
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 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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.
This letter immediately will allow you to begin marketing your device as described in your 510(k) premarket notification. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA. 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), promotion, or advertising please contact the Office of Compliance, Promotion and Advertising Policy Staff (HFZ-300) at (301) 594-4639. Other general information on your responsibilities under the Act
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may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597.
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D.
Acting Director
Division of Cardiovascular,
Respiratory, and Neurological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
