Vital-Port Petiet Polysulfone Vascular Access System

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

510(k) Number

K951077 ↗

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 primary purpose of the Vital-Port Petiet system?

  This device is designed to provide repeated vascular access for patients requiring therapy. It facilitates clinical procedures such as infusion therapy, injection, and blood sampling through an implanted, subcutaneous, intravascular port and catheter.

• Who is the manufacturer of this vascular access system?

  The Vital-Port Petiet Polysulfone Vascular Access System is supplied by Med Institute, Inc., located in West Lafayette, Indiana.

• What is the regulatory status of this device?

  The device has received FDA 510(k) clearance, which indicates that it has been found to be substantially equivalent to other legally marketed devices for the same intended use.

• In what clinical environment is this device intended to be used?

  The system is categorized for use within a general hospital setting, where it is utilized for managing long-term or repeated vascular access needs for patient care.