Nexus Detachable Coil, Multi-Diameter CSR and Helix Super Soft CSR
FDA 510(k) K051560 · Micro Therapeutics, Inc.
510(k) numberK051560
Submission
- Device name
- Nexus Detachable Coil, Multi-Diameter CSR and Helix Super Soft CSR
- Applicant
- Micro Therapeutics, Inc.
Irvine, CA, US - Received
- June 13, 2005
- Decision date
- June 28, 2005
- 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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| K051425 | Nexus Detachable Coil System, Helix Super Soft CSRHCG · Special | 06/22/2005SE |
| K050543 | Nexus Detachable Coil SystemHCG · Traditional | 04/27/2005SE |
Questions and answers
When was Nexus Detachable Coil, Multi-Diameter CSR and Helix Super Soft CSR cleared by the FDA?
Nexus Detachable Coil, Multi-Diameter CSR and Helix Super Soft CSR (K051560) received a 510(k) decision of Substantially Equivalent on June 28, 2005, 15 days after the submission was received.
What is the product code of K051560?
The FDA product code is HCG – Device, Neurovascular Embolization, a Class II (moderate risk) device regulated under 21 CFR 882.5950.