Micrus Microcoil Delivery System, MDS03
FDA 510(k) K002056 · Micrus Corp.
510(k) numberK002056
Submission
- Device name
- Micrus Microcoil Delivery System, MDS03
- Applicant
- Micrus Corp.
Mountain View, CA, US - Received
- July 6, 2000
- Decision date
- January 11, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K031578 | Micrus Microcoil Systems, Models Hel, SPH, STR, FSR and HSRHCG · Traditional | 08/01/2003SE |
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Questions and answers
When was Micrus Microcoil Delivery System, MDS03 cleared by the FDA?
Micrus Microcoil Delivery System, MDS03 (K002056) received a 510(k) decision of Substantially Equivalent on January 11, 2001, 189 days after the submission was received.
What is the product code of K002056?
The FDA product code is HCG – Device, Neurovascular Embolization, a Class II (moderate risk) device regulated under 21 CFR 882.5950.