Sapphire Detachable Fibered Coil System, Helix Fibered, Cyclone, Multiple Models
FDA 510(k) K033372 · Micro Therapeutics, Inc.
510(k) numberK033372
Submission
- Device name
- Sapphire Detachable Fibered Coil System, Helix Fibered, Cyclone, Multiple Models
- Applicant
- Micro Therapeutics, Inc.
Irvine, CA, US - Received
- October 22, 2003
- Decision date
- January 9, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 Sapphire Detachable Fibered Coil System, Helix Fibered, Cyclone, Multiple Models cleared by the FDA?
Sapphire Detachable Fibered Coil System, Helix Fibered, Cyclone, Multiple Models (K033372) received a 510(k) decision of Substantially Equivalent on January 9, 2004, 79 days after the submission was received.
What is the product code of K033372?
The FDA product code is HCG – Device, Neurovascular Embolization, a Class II (moderate risk) device regulated under 21 CFR 882.5950.