Contour Emboli

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

510(k) Number

K944354 ↗

FDA Product Code

HCG

Device Class

Class II

Regulation

21 CFR Part 882.5950

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Occlusion Balloon Catheter

  Class II

  FDA 510(k) K960832 Active Cleared 29 May 1996

• Radiopaque Spherical Emboli (Rse)

  Class II

  FDA 510(k) K871047 Active Cleared 22 May 1987

• Catheter, Balloon Type

  Class II

  FDA 510(k) K950398 Active Cleared 5 Oct 1995

• Itc Coaxial Angiographic Cath Set, Modification

  Class II

  FDA 510(k) K912477 Active Cleared 5 Nov 1991

• Itc Introducer Catheter

  Class II

  FDA 510(k) K900756 Active Cleared 8 Aug 1990

• Percutaneous Dilator with Sheath

  Class II

  FDA 510(k) K913932 Active Cleared 22 Nov 1991

See all devices from Interventional Therapeutics Corp. →

• What is the Contour Emboli used for in medical practice?

  The Contour Emboli is designed specifically for neurovascular embolization, targeting the occlusion of blood vessels in the brain. It is intended to treat vascular abnormalities such as arteriovenous malformations (AVMs) or aneurysms by delivering embolic material to block blood flow selectively. This helps isolate problematic areas while preserving surrounding healthy tissue, making it critical for managing complex neurovascular conditions in interventional radiology or neurosurgery.

• Is the Contour Emboli intended for single-use or repeated use?

  The Contour Emboli is supplied as a single-use device. This design ensures sterility and safety, as it is intended for one-time use in sterile procedures. Reusing the device is not recommended or supported by the manufacturer, aligning with standard medical device protocols for single-use items.

• What regulatory approval does the Contour Emboli hold?

  The Contour Emboli holds FDA 510(k) clearance under the reference number K944354. It is classified as a Class II device under regulation 882.5950, indicating it has been determined to be substantially equivalent to a legally marketed predicate device. This clearance ensures it meets the necessary safety and effectiveness standards for neurovascular embolization procedures.

• Can the Contour Emboli be used in MRI environments?

  No, the Contour Emboli is explicitly stated as not MRI-compatible. This means it should not be used in magnetic resonance imaging environments, as the device could be affected by magnetic fields or may pose risks to patients or operators during MRI procedures.

• What storage or handling instructions are provided for the Contour Emboli?

  The Contour Emboli must be handled according to standard sterile procedures due to its single-use nature. No additional storage or reprocessing instructions are specified beyond adhering to typical protocols for single-use medical devices. Ensuring sterility before use is critical, as the device is intended for direct application in interventional radiology or neurosurgery settings.