SYNCRUS INTERNAL CARDIOVERSION SYSTEM— 510(k) K020701
Substantially EquivalentGuidant Corporation, Cardiac Surgery
FDA 510(k) clearance K020701 for SYNCRUS INTERNAL CARDIOVERSION SYSTEM, Substantially Equivalent on 2002-05-24. Applicant: Guidant Corporation, Cardiac Surgery. Device class: 2.
Clearance details
- Applicant
- Guidant Corporation, Cardiac Surgery
- Product code
- Code NHW
- Device class
- Class 2
- Regulation
- 21 CFR 870.3680
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Clara, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.