ACS SOF-T GUIDE WIREE— 510(k) K840795
Substantially EquivalentAdvanced Cardiovascular Systems, Inc.
FDA 510(k) clearance K840795 for ACS SOF-T GUIDE WIREE, Substantially Equivalent on 1984-07-02. Applicant: Advanced Cardiovascular Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Product code
- Code DQT
- Device class
- Class 2
- Regulation
- 21 CFR 870.1370
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
Recent devices under product code DQT
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Data sourced from openFDA. This site is unofficial and independent of the FDA.