Intravascular Imaging Systems
FDA 510(k) K900305 · Intertherapy, Inc.
510(k) numberK900305
Submission
- Device name
- Intravascular Imaging Systems
- Applicant
- Intertherapy, Inc.
Costa Mesa, CA, US - Received
- January 21, 1990
- Decision date
- April 20, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LYK – Angioscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code LYK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253842 | Vena MicroAngioscope SystemLYK · Traditional | Vena Medical Holdings Corp | 01/28/2026SE |
| K251767 | Vena MicroAngioscope SystemLYK · Traditional | Vena Medical Holdings Corp | 10/01/2025SE |
| K062340 | Cardiooptics Augmentative Cardiac Optical Imaging SystemLYK · Traditional | Cardio-Optics, Inc. | 11/30/2006SE |
| K050808 | Coronary Sinus Access Kit, Model KCS8F-01LYK · Traditional | Cardio-Optics, Inc. | 07/28/2005SE |
| K011793 | Ksea FiberscopeLYK · Traditional | KARL STORZ Endoscopy-America, Inc. | 04/17/2002SE |
| K012724 | Smith & Nephew Vascular Videoendoscope System, Model 7209273LYK · Traditional | Smith & Nephew, Inc. | 11/08/2001SE |
| 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 |
| K951721 | Applied Medical 1.5MM Reusable AngioscopeLYK · Traditional | Applied Medical Resources | 07/11/1995SE |
More from Applied Medical Resources
| 510(k) | Device | Decision |
|---|---|---|
| K913763 | Interpret(Tm) Catheter Linear TranslatorLYK · Traditional | 11/20/1991SE |
| K912600 | Interpret(Tm) Intravascular Imaging CatheterITX · Traditional | 11/19/1991SE |
| K910281 | Intravascular Imaging System/ModifiedJOP · Traditional | 05/13/1991SE |
| K895159 | Intravascular Imaging SystemLYK · Traditional | 03/12/1990SE |
Questions and answers
When was Intravascular Imaging Systems cleared by the FDA?
Intravascular Imaging Systems (K900305) received a 510(k) decision of Substantially Equivalent on April 20, 1990, 89 days after the submission was received.
What is the product code of K900305?
The FDA product code is LYK – Angioscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.