Coronary Stent

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FDA PMA for Coronary Stent

A Coronary Stent (Cardiovascular Stent) is defined as “a metal scaffold placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen”. In other words, stents are implantable scaffolds that keep blood vessels open.

Intended Use of Coronary Stent

A Coronary Stent is a metal scaffold intended to be placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen.

For a detailed proposal with a Statement of Work, please complete the Request for Quote (RFQ) form provided separately for FDA 510(k) and MDR CE Marking for Coronary Stent
REQUEST 510K QUOTE
REQUEST MDR CE MARKING QUOTE

FDA 510K for Drug Eluting Stents Device Code and Regulation Number

S. No

 Product Code

Device

Class

1

MAF

Stent, Coronary

3

Drug Coated Stents - Drug Eluting Stents

A coronary stent is a metal scaffold that is delivered via a catheter into the coronary artery or saphenous vein graft to provide mechanical support and maintain lumen patency of the treated vessel following a percutaneous intervention. The stent is intended to remain permanently implanted to prevent vessel closure or restenosis after angioplasty.

Device Description:

A coronary stent is an implantable vascular scaffold typically fabricated from metallic materials (e.g., cobalt-chromium, stainless steel, nitinol) and designed for percutaneous delivery. The stent is mounted on a balloon catheter or self-expanding delivery system and is expanded at the target lesion to support the vessel walls. After deployment, the stent remains in place to maintain vessel lumen diameter and prevent acute recoil or closure.

  • Scaffold geometry: strut thickness, cell pattern
  • Delivery system: catheter compatible with common guide wires and sheaths
  • Materials: biocompatible metals designed to limit corrosion and fatigue
  • Profiles: balloon-expandable or self-expanding variants
  • Functional features: radial strength, flexibility, conformability

Performance Testing (Analytical) for Coronary Stent:

  • Mechanical & Structural
  • Radial strength & chronic outward force
  • Recoil and foreshortening
  • Flexibility & trackability
  • Fatigue durability
  • Expansion behavior
  • Dimensional & Material Characterization
  • Scaffold geometry and manufacturing tolerances
  • Surface finish, strut thickness uniformity
  • Material composition and microstructure,
  • Delivery System Testing
  • Push/pull force
  • Compatibility with guide catheters and introducers
  • Sheath integrity and deployment consistency
  • In Vitro Functional Testing
  • Coronary vessel simulation studies (flow loop models)
  • Particulate and debris assessment
  • Simulated use testing (deployment in physiologic models)
  • Animal (In Vivo) Studies
  • Biocompatibility (ISO 10993 Series)
  • Sterilization & Shelf-Life
  • Imaging Compatibility
  • Fluoroscopy visibility assessment
  • Artifacts (if MRI claims are made, follow ASTM F standards)
  • MRI safety evaluation if labeling includes MR conditions
  • Corrosion & Fatigue Life
  • Electrochemical corrosion testing
  • Long-term fatigue/durability under cyclic loading

Clinical Testing:

Required

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