Meerci Retriever, Concentric Microcatheter, Models 90050, 90060, 90065, 90066, 90070,90092, 90043, 90044
FDA 510(k) K072796 · Concentric Medical, Inc.
510(k) numberK072796
Submission
- Device name
- Meerci Retriever, Concentric Microcatheter, Models 90050, 90060, 90065, 90066, 90070,90092, 90043, 90044
- Applicant
- Concentric Medical, Inc.
Mountain View, CA, US - Received
- October 1, 2007
- Decision date
- December 18, 2007
- 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 Meerci Retriever, Concentric Microcatheter, Models 90050, 90060, 90065, 90066, 90070,90092, 90043, 90044 cleared by the FDA?
Meerci Retriever, Concentric Microcatheter, Models 90050, 90060, 90065, 90066, 90070,90092, 90043, 90044 (K072796) received a 510(k) decision of Substantially Equivalent on December 18, 2007, 78 days after the submission was received.
What is the product code of K072796?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.