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510(k) K191731

Instylla Microcatheter by Instylla, Inc. — Product Code KRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2019
Date Received
June 28, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Continuous Flush
Device Class
Class II
Regulation Number
870.1210
Review Panel
CV
Submission Type

Other clearances by Instylla, Inc.

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  • K202544 — Instylla Delivery Kit (January 7, 2021)
  • K200744 — Instylla Microcatheter (April 21, 2020)
  • K191659 — Instylla Delivery Kit (October 10, 2019)

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