4.5F Imagecath Coronary Angioscope, Model COV45

No FDA recalls found in the data synced 6 Oct 2026.

Full name

4.5F Imagecath Coronary Angioscope, Model COV45 [Subsequently Referred to As the Modified Angioscope[

510(k) Number

K952638 ↗

FDA Product Code

LYK

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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• What is the 4.5F Imagecath Coronary Angioscope used for?

  The 4.5F Imagecath Coronary Angioscope is a medical device designed for coronary angioscopy, allowing visualization of the coronary arteries. It provides internal imaging of blood vessels for diagnostic purposes in medical procedures.

• Is the angioscope reusable or single-use?

  The 4.5F Imagecath Coronary Angioscope is supplied as a single-use device and is not intended for reuse. This design ensures patient safety and prevents cross-contamination between procedures.

• What are the storage requirements for this device?

  The angioscope should be stored according to the manufacturer's guidelines. While specific storage conditions aren't detailed in the provided information, it's important to follow the manufacturer's recommendations to maintain device integrity and functionality.

• What regulatory approvals does this device have?

  The 4.5F Imagecath Coronary Angioscope has received FDA 510(k) clearance with the product code LYK. It is classified as a class II device for use in gastroenterology and urology specialties.