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510(k) K191237

CERENOVUS Large Bore Catheter by Codman & Shurtleff, Inc. — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2019
Date Received
May 8, 2019
Clearance Type
Traditional
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

Other clearances by Codman & Shurtleff, Inc.

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  • K172022 — CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) (October 3, 2017)
  • K171862 — GALAXY G3 Mini Microcoil Delivery System (September 25, 2017)
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  • K171653 — YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up (July 3, 2017)
  • K162563 — YOGA Microcatheter (January 5, 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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