Fibered GDC-18 Vortx Shape Guglielmi Detachable Coil
FDA 510(k) K993418 · Boston Scientific, Target
510(k) numberK993418
Submission
- Device name
- Fibered GDC-18 Vortx Shape Guglielmi Detachable Coil
- Applicant
- Boston Scientific, Target
Fremont, CA, US - Received
- October 1, 1999
- Decision date
- January 21, 2000
- 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 |
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| 510(k) | Device | Decision |
|---|---|---|
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| K031168 | Matrix Stretch Resistant Detachable CoilHCG · Special | 05/14/2003SE |
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| K022860 | Atlantis PV Imaging Catheter, Model 36456ITX · Special | 11/21/2002SE |
| K022357 | Transend 300 Es Guidewire, Model 46-814 & Transend 300 Floppy Guidewire, Model 46-815DQX · Traditional | 10/16/2002SE |
| K021494 | GDC Power Supply, Model GDC Power Supply: 451007-4HCG · Special | 06/06/2002SE |
| K014109 | In-Time Retrieval DeviceMMX · Traditional | 03/12/2002SE |
| K012985 | Matrix Detachable CoilsHCG · Traditional | 01/31/2002SE |
| K013789 | Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189DQY · Special | 12/06/2001SE |
| K010853 | Guider Softip Guiding Catheter XF 5FDQY · Special | 04/18/2001SE |
Questions and answers
When was Fibered GDC-18 Vortx Shape Guglielmi Detachable Coil cleared by the FDA?
Fibered GDC-18 Vortx Shape Guglielmi Detachable Coil (K993418) received a 510(k) decision of Substantially Equivalent on January 21, 2000, 112 days after the submission was received.
What is the product code of K993418?
The FDA product code is HCG – Device, Neurovascular Embolization, a Class II (moderate risk) device regulated under 21 CFR 882.5950.