VYGON 2 FR EPICUTANEO PUR-CATHETER

K993052 · Vygon Corp. · LJS · Aug 3, 2000 · General Hospital

Device Facts

• Record ID: K993052
• Device Name: VYGON 2 FR EPICUTANEO PUR-CATHETER
• Applicant: Vygon Corp.
• Product Code: LJS · General Hospital
• Decision Date: Aug 3, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5970
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Vygon 2 FR Epicutaneo PUR Catheter is intended for use in neonates who require form from therapy, drugs for pain management or intravenous fluids.

Device Story

The Vygon 2 FR Epicutaneo PUR Catheter is a medical device designed for neonatal use. It serves as a conduit for the administration of intravenous fluids, pain management medications, and other necessary therapies. The device is intended for use in a clinical setting, typically managed by healthcare professionals such as physicians or nurses. By providing a reliable venous access point, the catheter facilitates the delivery of essential treatments, thereby supporting the clinical management of neonates requiring intravenous intervention.

Clinical Evidence

no clinical data

Technological Characteristics

The device is a 2 French catheter constructed from polyurethane (PUR). It is designed for neonatal intravenous access.

Indications for Use

Indicated for neonates requiring intravenous therapy, pain management drugs, or intravenous fluids.

Regulatory Classification

Identification

A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.

Special Controls

*Classification.* Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3 2000 AUG

Mr. Robert Schiff President Schiff & Company 1129 Bloomfield Avenue West Caldwell, New Jersey 07006

K993052 Re: Vygon 2 FR Epicutaneo PUR-Catheter Trade Name: Requlatory Class: II Product Code: LJS May 26, 2000 Dated: "May 30, 2000 Received:

Dear Mr. Schiff:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the market the actrantially equivalent (for the indications for use stated in the enclosure) to legally marketed pređicate use stated in the chorobate, commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to che enacement awe been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). provisions of the rouseds 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. ਜ 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 In addition, FDA may publish further announcements action. 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. Schiff

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 requlation (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, płease note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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510(k) PREMARKET NOTIFIC VYGON, EAST RUTHERFORD, NJ 2 FR EPICUTANEO PUR CATHETER

## INDICATIONS FOR USE STATEMENT

K99 305-2

510(k) Number (if known): Device Name:

Not assigned yet Vygon 2 FR Epicutaneo PUR Catheter.

Indications for Use:

The Vygon 2 FR Epicutaneo PUR Catheter is intended for use in neonates who The Vygon 2 1 t t = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = require form from therapy, drugs for pain management or intravenous fluids.

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Concurrence of CDRH, Office of Device Evaluation {OBE}

Prescription Use

OR

Over-The-Counter Use

(Per 21 CFER 801.109)

(Optional Format 1-2-96)

Patricia Cosciente

(Division Sign-Off Division of Dental. Info and General Hos 510(k) Number