Bare Platinum Framing Coil, Model(S) 100408BPFC-V,100412BPFC-V,100515BPFC-V100518BPFC-V,100522BPFC-V,100618BPFC-V100622B
FDA 510(k) K082461 · MicroVention, Inc.
510(k) numberK082461
Submission
- Device name
- Bare Platinum Framing Coil, Model(S) 100408BPFC-V,100412BPFC-V,100515BPFC-V100518BPFC-V,100522BPFC-V,100618BPFC-V100622B
- Applicant
- MicroVention, Inc.
Aliso Viejo, CA, US - Received
- August 27, 2008
- Decision date
- October 2, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Bare Platinum Framing Coil, Model(S) 100408BPFC-V,100412BPFC-V,100515BPFC-V100518BPFC-V,100522BPFC-V,100618BPFC-V100622B cleared by the FDA?
Bare Platinum Framing Coil, Model(S) 100408BPFC-V,100412BPFC-V,100515BPFC-V100518BPFC-V,100522BPFC-V,100618BPFC-V100622B (K082461) received a 510(k) decision of Substantially Equivalent on October 2, 2008, 36 days after the submission was received.
What is the product code of K082461?
The FDA product code is HCG – Device, Neurovascular Embolization, a Class II (moderate risk) device regulated under 21 CFR 882.5950.