Who is the manufacturer of R-PORT STANDARD IMPLANTABLE VASCULAR ACCESS SYSTEM?

Boston Scientific Corp filed the 510(k) submission for R-PORT STANDARD IMPLANTABLE VASCULAR ACCESS SYSTEM (K964538).

What is the FDA product code for R-PORT STANDARD IMPLANTABLE VASCULAR ACCESS SYSTEM?

LJT. It is classified under 21 CFR 880.5965 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for R-PORT STANDARD IMPLANTABLE VASCULAR ACCESS SYSTEM?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like R-PORT STANDARD IMPLANTABLE VASCULAR ACCESS SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

R-PORT STANDARD IMPLANTABLE VASCULAR ACCESS SYSTEM

K964538 · Boston Scientific Corp · LJT · Mar 10, 1997 · General Hospital

Device Facts

Record ID	K964538
Device Name	R-PORT STANDARD IMPLANTABLE VASCULAR ACCESS SYSTEM
Applicant	Boston Scientific Corp
Product Code	LJT · General Hospital
Decision Date	Mar 10, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5965
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Implantation of a port and catheter is indicated whenever patient therapy requires repeated intravascular injection or continuous infusion of fluids, medications, antibiotics, nutritionals and the withdrawal of venous blood samples.

Device Story

Vascular access system; consists of low-profile subcutaneous port with injectable septum and detached catheter; includes non-coring stainless steel needle. Implanted in chest wall or arm by physician. Provides access for repeated intravascular injection, continuous infusion of fluids/medications/nutritionals, and blood withdrawal. Benefits patient by facilitating long-term venous access while minimizing repeated venipuncture.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Low-profile port with injectable septum; detached catheter; stainless steel non-coring needle. Sterilization: Ethylene oxide gas. Packaging: PETG blister tray with Tyvek lid.

Indications for Use

Indicated for patients requiring repeated intravascular access for fluid/medication infusion, nutritional support, or venous blood sampling.

Regulatory Classification

Identification

A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.

Special Controls

*Classification.* Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.

Predicate Devices

Therex low profile ports

Related Devices

K153359 — BardPort®, SlimPort®, and X-Port® Implanted Ports · C.R. Bard, Inc. · May 20, 2016
K032044 — X-PROT DUO PORT · C.R. Bard, Inc. · Jul 10, 2003
K034065 — MODIFICATION TO X-PORT DUO PORT · C.R. Bard, Inc. · Jan 15, 2004
K251253 — PowerPort isp Implantable Port; PowerPort Slim Implantable Port; PowerPort M.R.I. Implantable Port; PowerPort M.R.I. isp Implantable Port · Bard Access Systems, Inc. · Jun 18, 2025
K122402 — LPP (LOW PROFILE PORT) · Pfm Medical, Inc. · Jul 16, 2013

Submission Summary (Full Text)

{0} MAR 10 1997 X964538 # SUMMARY OF SAFETY AND EFFECTIVENESS Pursuant to §513(i)(3)(A) of the Food, Drug, and cosmetic Act, Boston Scientific Corporation submits this summary of safety and effectiveness. ## A. GENERAL INFORMATION Owner Operator Submitting Boston Scientific Corporation this Premarket Notification: One Boston Scientific Place Natick, MA 01757 (508) 650.8174 Contact Person: Wanda M. Carpinella Regulatory Affairs Department Device Generic Name: Venous Access Port Kit Device Classification: 80 LJT, Implanted Subcutaneous Port and Catheter ## B. INDICATIONS FOR USE Implantation of a port and catheter is indicated whenever patient therapy requires repeated intravascular injection or continuous infusion of fluids, medications, antibiotics, nutritionals and the withdrawal of venous blood samples. ## C. DESCRIPTIVE CHARACTERISTICS The device is a vascular access system consisting of an low profile port with an injectable septum and a detached catheter. The low profile port is suitable for arm placement or for implantation in the chest wall. A non-coring, stainless steel needle is supplied with each port. ## D. SUBSTANTIAL EQUIVALENCE The proposed port has been shown to be substantially equivalent to Therex's low profile ports. ## E. PACKAGING, STERILIZATION, AND PYROGENICITY The low profile port is packaged in a PETG blister tray covered with a heat-sealed Tyvek lid. The product is sterilized using ethylene oxide gas. Bacterial endotoxin levels are monitored for sterility release purposes. ## F. CONCLUSION Based on the information presented, Boston Scientific Corporation believes that the proposed low profile port meets the minimum requirements that are considered acceptable for its intended use and is substantially equivalent to other currently marketed vascular access port and catheter systems. 00010