Axium Detachable Coil System
FDA 510(k) K151447 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
510(k) numberK151447
Submission
- Device name
- Axium Detachable Coil System
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Irvine, CA, US - Received
- May 29, 2015
- Decision date
- July 28, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K242582 | Optima Coil System (OptiBlock Line Extension)HCG · Special | Balt USA, LLC | 09/27/2024SE |
| K242243 | Target Detachable CoilsHCG · Special | Stryker Neurovscular | 08/29/2024SE |
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Questions and answers
When was Axium Detachable Coil System cleared by the FDA?
Axium Detachable Coil System (K151447) received a 510(k) decision of Substantially Equivalent on July 28, 2015, 60 days after the submission was received.
What is the product code of K151447?
The FDA product code is HCG – Device, Neurovascular Embolization, a Class II (moderate risk) device regulated under 21 CFR 882.5950.