Applied Medical 1.5MM Reusable Angioscope
FDA 510(k) K951721 · Applied Medical Resources
510(k) numberK951721
Submission
- Device name
- Applied Medical 1.5MM Reusable Angioscope
- Applicant
- Applied Medical Resources
Launa Hills, CA, US - Received
- April 14, 1995
- Decision date
- July 11, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LYK – Angioscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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| K001408 | Ksea Vascular FiberscopesLYK · Traditional | KARL STORZ Endoscopy-America, Inc. | 10/30/2000SE |
| K964061 | Gore Angioscopic Valvvlotome Kit (TBD)LYK · Traditional | W. L. Gore & Associates, Inc. | 02/20/1997SE |
| K952638 | 4.5F Imagecath Coronary Angioscope, Model COV45 [Subsequently Referred to AS the…LYK · Traditional | Baxter Edwards | 07/28/1995SE |
| K945591 | Applied Medical Optical ValvulotomeLYK · Traditional | Applied Medical Resources | 02/10/1995SE |
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Questions and answers
When was Applied Medical 1.5MM Reusable Angioscope cleared by the FDA?
Applied Medical 1.5MM Reusable Angioscope (K951721) received a 510(k) decision of Substantially Equivalent on July 11, 1995, 88 days after the submission was received.
What is the product code of K951721?
The FDA product code is LYK – Angioscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.