4.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV45— 510(k) K926433
Substantially EquivalentBaxter Edwards
FDA 510(k) clearance K926433 for 4.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV45, Substantially Equivalent on 1993-03-23. Applicant: Baxter Edwards. Device class: 2.
Clearance details
- Applicant
- Baxter Edwards
- Product code
- Code LYK
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.