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510(k) K180986

XableCath Support Catheter Product Family by Xablecath, Inc. — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2018
Date Received
April 16, 2018
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

Other clearances by Xablecath, Inc.

  • K183357 — XableCath Crossing Catheter (January 21, 2019)
  • K170041 — XableCath Support Catheter (September 7, 2017)

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