Micrus Microcatheter Courier Pre-Shaped, Models MPS170045-00, MPS170090-00, MPS190045-00, MPS190090-00
FDA 510(k) K061963 · Micrus Endovascular Corporation
510(k) numberK061963
Submission
- Device name
- Micrus Microcatheter Courier Pre-Shaped, Models MPS170045-00, MPS170090-00, MPS190045-00, MPS190090-00
- Applicant
- Micrus Endovascular Corporation
San Jose, CA, US - Received
- July 12, 2006
- Decision date
- August 4, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
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Questions and answers
When was Micrus Microcatheter Courier Pre-Shaped, Models MPS170045-00, MPS170090-00, MPS190045-00, MPS190090-00 cleared by the FDA?
Micrus Microcatheter Courier Pre-Shaped, Models MPS170045-00, MPS170090-00, MPS190045-00, MPS190090-00 (K061963) received a 510(k) decision of Substantially Equivalent on August 4, 2006, 23 days after the submission was received.
What is the product code of K061963?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.