Workstation Femoral Intravascular Retrieval (MODI)

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

510(k) Number

K914555 ↗

FDA Product Code

DRE

Device Class

Class II

Regulation

21 CFR Part 870.1310

Advisory Committee

Cardiovascular

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 MODI Workstation Femoral Retrieval Dilator used for?

  The MODI Workstation Femoral Retrieval Dilator is designed specifically for intravascular access and retrieval procedures in the femoral region. It facilitates the removal of emboli, thrombi, or other obstructions within blood vessels, supporting interventional cardiology and vascular interventions. Its primary purpose is to enable precise navigation and retrieval of intravascular debris during percutaneous techniques, ensuring safe and effective vascular access.

• How is the MODI Workstation Femoral Retrieval Dilator supplied and intended for use?

  This device is supplied as a single-use, sterile medical device intended exclusively for controlled clinical settings such as catheterization labs or interventional radiology suites. Its sterile packaging ensures safety for one-time use per procedure, reducing the risk of contamination or cross-infection. The design aligns with percutaneous catheterization techniques, making it ideal for specialized vascular interventions.

• Is the MODI Workstation Femoral Retrieval Dilator reusable or single-use?

  The MODI Workstation Femoral Retrieval Dilator is explicitly designed for single-use only. This classification aligns with FDA guidelines for Class II medical devices and ensures patient safety by preventing reuse-related contamination risks. Each unit is intended for one procedure, after which it must be discarded according to standard medical waste protocols.

• What reference codes or configurations are available for the MODI Workstation?

  The MODI Workstation Femoral Retrieval Dilator is available in multiple reference configurations, including codes such as 2527072, 3009211636, and others listed in the FDA submission. These variations likely correspond to different sizes or technical specifications tailored for specific clinical needs. For precise sizing or additional details, consult the manufacturer’s documentation or contact Med Institute, Inc.

• How should the MODI Workstation Femoral Retrieval Dilator be stored?

  Storage of the MODI Workstation Femoral Retrieval Dilator follows standard sterile medical device protocols. It must be kept in its original, unopened packaging to maintain sterility until immediate use. Store in a clean, dry environment away from direct sunlight or extreme temperatures, adhering to the manufacturer’s guidelines to preserve functionality and sterility. Always check expiration dates before use.