Inzone Detachment System, Model M00345100940, Izds Connecting Cable, Model M00345100250
FDA 510(k) K092666 · Boston Scientific Corp
510(k) numberK092666
Submission
- Device name
- Inzone Detachment System, Model M00345100940, Izds Connecting Cable, Model M00345100250
- Applicant
- Boston Scientific Corp
Fremont, CA, US - Received
- August 31, 2009
- Decision date
- September 30, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Inzone Detachment System, Model M00345100940, Izds Connecting Cable, Model M00345100250 cleared by the FDA?
Inzone Detachment System, Model M00345100940, Izds Connecting Cable, Model M00345100250 (K092666) received a 510(k) decision of Substantially Equivalent on September 30, 2009, 30 days after the submission was received.
What is the product code of K092666?
The FDA product code is HCG – Device, Neurovascular Embolization, a Class II (moderate risk) device regulated under 21 CFR 882.5950.