Detach 18 and Detach 11, Neurological Embolization Coil System
FDA 510(k) K000651 · Cook, Inc.
510(k) numberK000651
Submission
- Device name
- Detach 18 and Detach 11, Neurological Embolization Coil System
- Applicant
- Cook, Inc.
Bloomington, IN, US - Received
- February 28, 2000
- Decision date
- November 24, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Detach 18 and Detach 11, Neurological Embolization Coil System cleared by the FDA?
Detach 18 and Detach 11, Neurological Embolization Coil System (K000651) received a 510(k) decision of Substantially Equivalent on November 24, 2000, 270 days after the submission was received.
What is the product code of K000651?
The FDA product code is HCG – Device, Neurovascular Embolization, a Class II (moderate risk) device regulated under 21 CFR 882.5950.