ACS ANGIOSCOPE GUIDE WIRE— 510(k) K883000
Substantially EquivalentAdvanced Cardiovascular Systems, Inc.
FDA 510(k) clearance K883000 for ACS ANGIOSCOPE GUIDE WIRE, Substantially Equivalent on 1988-09-28. Applicant: Advanced Cardiovascular Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Advanced Cardiovascular Systems, Inc.
- 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
- Mountain View, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.