PULSE*SPRAY INFUSION SYSTEM

K961763 · Angiodynamics, Div. E-Z-Em, Inc. · QEY · Jul 17, 1996 · Cardiovascular

Device Facts

• Record ID: K961763
• Device Name: PULSE*SPRAY INFUSION SYSTEM
• Applicant: Angiodynamics, Div. E-Z-Em, Inc.
• Product Code: QEY · Cardiovascular
• Decision Date: Jul 17, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pulse*Spray® System, PRO™ Infusion Catheter, and its related components, are intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral vasculature.

Device Story

Pulse*Spray Infusion System is a catheter-based device designed for targeted delivery of fluids into peripheral vasculature. It facilitates administration of thrombolytic agents and contrast media. Used by clinicians in clinical settings to manage vascular conditions requiring localized infusion. Device functions as a conduit for fluid delivery; operation involves standard catheterization techniques. Benefits include precise, localized therapeutic delivery, potentially improving outcomes in patients requiring thrombolysis or diagnostic imaging.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on administrative review of 510(k) notification.

Technological Characteristics

Catheter-based infusion system for peripheral vasculature. Mechanical device for fluid delivery. No software, electronics, or energy source described.

Indications for Use

Indicated for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral vasculature of patients requiring such therapy.

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
603 Queensbury Ave.
Queensbury, New York 12804

Re: K961763
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 July 17, 1996. 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, [phone], [e-mail].

Sincerely,

Gregory W. O'connell - S
Digitally signed by Gregory W. O'connell - S
Date: 2021.11.22
13:50:19 -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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUL 17 1996

Mr. Brian Kunst
Director of Regulatory Affairs/
Quality Assurance
AngioDynamics
603 Queensbury Avenue
Queensbury, New York 12804

Re: K961763
Pulse* Spray® Infusion System
Regulatory Class: II(two)
Product Code: KRA
Dated: May 3, 1996
Received: May 7, 1996

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 (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 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, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in

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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.

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone].

Sincerely yours,

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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K961763/A

Page 1 of 1

510(k) Number (if known): K961763

Device Name: Pulse*Spray Infusion System

Indications For Use:

The Pulse*Spray® System, PRO™ Infusion Catheter, and its related components, are intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral vasculature.

T. A. R.

(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K961763

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use or Over-The-Counter Use

(Per 21 CFR 801.109)

(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K961763

(Optional Format 1-2-96)