Vital-Port M.R.I. Dual Lumen Vascular Access Syst.

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K921201 ↗

FDA Product Code

LJT

Device Class

Class II

Regulation

21 CFR Part 880.5965

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Vital-Port Infusion Pal

  Class II

  FDA 510(k) K971140 Active Cleared 17 Nov 1997

• Vital-Port Vascular Access System

  Class II

  FDA 510(k) K911449 Active Cleared 24 Jun 1991

• Vital-Port M.R.I. Vascular Access System 7012, 7112

  Class II

  FDA 510(k) K912423 Active Cleared 30 Jul 1991

• Vital-Port Mini Vascular Access System

  Class II

  FDA 510(k) K931586 Active Cleared 27 Sep 1993

• Byrd Telescoping Stainless Steel Dilat Sheath Set

  Class I

  FDA 510(k) K922354 Active Cleared 30 Jul 1992

• Wilson-Cook Colonic Z-Stent

  Class II

  FDA 510(k) K990034 Active Cleared 17 Apr 2000

See all devices from Med Institute, Inc. →

• What is the Vital-Port MRI Dual Lumen Vascular Access System used for?

  The Vital-Port MRI Dual Lumen Vascular Access System is designed for repeated vascular access in general hospital settings. It provides a subcutaneous, implanted reservoir connected to a long-term intravascular catheter, enabling simultaneous administration of multiple therapies or monitoring through its dual lumens. This setup is ideal for fluid infusion, medication delivery, and blood sampling without frequent needle insertions.

• Is the Vital-Port MRI Dual Lumen Vascular Access System MRI-compatible?

  Yes, the Vital-Port MRI Dual Lumen Vascular Access System is explicitly designed to be MRI-compatible. This means it can be used for imaging procedures without requiring removal, ensuring continuous access for patients who need both medical imaging and vascular therapy.

• How is the Vital-Port MRI Dual Lumen Vascular Access System supplied and intended for use?

  The system is supplied sterile and intended for single-use implantation. It is meant to be implanted subcutaneously, providing a long-term solution for vascular access. Proper storage and handling per manufacturer instructions are required to maintain its sterility and functionality throughout its intended use.

• Can the Vital-Port MRI Dual Lumen Vascular Access System be reused?

  No, the Vital-Port MRI Dual Lumen Vascular Access System is designed for single-use only. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and functionality, potentially leading to complications for the patient.

• What regulatory approval does the Vital-Port MRI Dual Lumen Vascular Access System hold?

  The Vital-Port MRI Dual Lumen Vascular Access System holds FDA 510(k) clearance under the product code LJT. It is classified as a Class II device and is authorized for use in general hospital settings. The clearance number is K921201, and it was originally submitted in 1992.