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510(k) K162563

YOGA Microcatheter by Codman & Shurtleff, Inc. — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 2017
Date Received
September 14, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

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  • K171653 — YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up (July 3, 2017)
  • K162437 — Codman EDS3 CSF External Drainage System (October 28, 2016)
  • K153347 — Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman (August 19, 2016)

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