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FDA 510(k), K122106, SPIN DRIVE ALWAYS-ON TIP TRACKED STEERABLE CATHETER ALWAYS-ON TIP TRACKED SHEATH ALWAYS-ON TIP TRACKED ASPIRATION NEEDLE
FDA 510(k), K122106, SPIN DRIVE ALWAYS-ON TIP TRACKED STEERABLE CATHETER ALWAYS-ON TIP TRACKED SHEATH ALWAYS-ON TIP TRACKED ASPIRATION NEEDLE
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510(K) Number: K122106
Device Name: SPIN DRIVE ALWAYS-ON TIP TRACKED STEERABLE CATHETER ALWAYS-ON TIP TRACKED SHEATH ALWAYS-ON TIP TRACKED ASPIRATION NEEDLE
Manufacturer: SCOTT WRIGHTSTONE
Device Classification Name: System, X-Ray, Tomography, Computed
Regulation Number: JAK
Classification Product Code: 07/17/2012
Date Received: 12/21/2012
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: SPIN DRIVE ALWAYS-ON TIP TRACKED STEERABLE CATHETER ALWAYS-ON TIP TRACKED SHEATH ALWAYS-ON TIP TRACKED ASPIRATION NEEDLE
Manufacturer: SCOTT WRIGHTSTONE
Device Classification Name: System, X-Ray, Tomography, Computed
Regulation Number: JAK
Classification Product Code: 07/17/2012
Date Received: 12/21/2012
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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