4.5F Imagecath(R) Coronary Angioscope, COV45
FDA 510(k) K926433 · Baxter Edwards
510(k) numberK926433
Submission
- Device name
- 4.5F Imagecath(R) Coronary Angioscope, COV45
- Applicant
- Baxter Edwards
Irvine, CA, US - Received
- December 23, 1992
- Decision date
- March 23, 1993
- 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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| 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 |
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| K955839 | Multi-Med Multi-Lumen Central Venous CatheterFOZ · Traditional | 03/25/1996SE |
| K952638 | 4.5F Imagecath Coronary Angioscope, Model COV45 [Subsequently Referred to AS the…LYK · Traditional | 07/28/1995SE |
| K944214 | Baxter Handle Model 1150DTJ · Traditional | 02/10/1995SE |
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Questions and answers
When was 4.5F Imagecath(R) Coronary Angioscope, COV45 cleared by the FDA?
4.5F Imagecath(R) Coronary Angioscope, COV45 (K926433) received a 510(k) decision of Substantially Equivalent on March 23, 1993, 90 days after the submission was received.
What is the product code of K926433?
The FDA product code is LYK – Angioscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.