GDC Power Supply, Model GDC Power Supply: 451007-4
FDA 510(k) K021494 · Boston Scientific, Target
510(k) numberK021494
Submission
- Device name
- GDC Power Supply, Model GDC Power Supply: 451007-4
- Applicant
- Boston Scientific, Target
Fremont, CA, US - Received
- May 9, 2002
- Decision date
- June 6, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was GDC Power Supply, Model GDC Power Supply: 451007-4 cleared by the FDA?
GDC Power Supply, Model GDC Power Supply: 451007-4 (K021494) received a 510(k) decision of Substantially Equivalent on June 6, 2002, 28 days after the submission was received.
What is the product code of K021494?
The FDA product code is HCG – Device, Neurovascular Embolization, a Class II (moderate risk) device regulated under 21 CFR 882.5950.