Penumbra Coil System/Penumbra Coil 400
FDA 510(k) K120330 · Penumbra, Inc.
510(k) numberK120330
Submission
- Device name
- Penumbra Coil System/Penumbra Coil 400
- Applicant
- Penumbra, Inc.
Alameda, CA, US - Received
- February 2, 2012
- Decision date
- April 2, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K242154 | Numen Coil Embolization System; NumenFR Detachment SystemHCG · Special | MicroPort NeuroTech (Shanghai) Co., Ltd. | 09/30/2024SE |
| 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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| K242075 | Indigo® Aspiration System Lightning Bolt Aspiration TubingQEW · Traditional | 09/25/2024SE |
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Questions and answers
When was Penumbra Coil System/Penumbra Coil 400 cleared by the FDA?
Penumbra Coil System/Penumbra Coil 400 (K120330) received a 510(k) decision of Substantially Equivalent on April 2, 2012, 60 days after the submission was received.
What is the product code of K120330?
The FDA product code is HCG – Device, Neurovascular Embolization, a Class II (moderate risk) device regulated under 21 CFR 882.5950.