1
/
of
0
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
Regular price
$89.00 USD
Regular price
Sale price
$89.00 USD
Unit price
/
per
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: KXA
Date Received: 07/17/2012
Decision Date: 12/21/2012
Decision: 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: KXA
Date Received: 07/17/2012
Decision Date: 12/21/2012
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Couldn't load pickup availability
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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.
View full details