Micrus Microcoil Delivery System, Models SPH, Hel, Che, PC4, HSR, FSR, CSP, CFS, SRC, PP4, STR
FDA 510(k) K071246 · Micrus Endovascular Corporation
510(k) numberK071246
Submission
- Device name
- Micrus Microcoil Delivery System, Models SPH, Hel, Che, PC4, HSR, FSR, CSP, CFS, SRC, PP4, STR
- Applicant
- Micrus Endovascular Corporation
San Jose, CA, US - Received
- May 3, 2007
- Decision date
- June 1, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Micrus Microcoil Delivery System, Models SPH, Hel, Che, PC4, HSR, FSR, CSP, CFS, SRC, PP4, STR cleared by the FDA?
Micrus Microcoil Delivery System, Models SPH, Hel, Che, PC4, HSR, FSR, CSP, CFS, SRC, PP4, STR (K071246) received a 510(k) decision of Substantially Equivalent on June 1, 2007, 29 days after the submission was received.
What is the product code of K071246?
The FDA product code is HCG – Device, Neurovascular Embolization, a Class II (moderate risk) device regulated under 21 CFR 882.5950.