REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICES— 510(k) K070034
Substantially EquivalentAscent Healthcare Solutions
FDA 510(k) clearance K070034 for REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICES, Substantially Equivalent on 2007-08-17. Applicant: Ascent Healthcare Solutions. Device class: 1.
Clearance details
- Applicant
- Ascent Healthcare Solutions
- Product code
- Code NQG
- Device class
- Class 1
- Regulation
- 21 CFR 870.4500
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Phoenix, AZ, US
Recent devices under product code NQG
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Data sourced from openFDA. This site is unofficial and independent of the FDA.