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510(k) K200744

Instylla Microcatheter by Instylla, Inc. — Product Code KRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 2020
Date Received
March 23, 2020
Clearance Type
Special
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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  • K213632 — Instylla Delivery Kit (February 10, 2022)
  • K210808 — Instylla Microcatheter 1.2 (April 15, 2021)
  • K202544 — Instylla Delivery Kit (January 7, 2021)
  • K191659 — Instylla Delivery Kit (October 10, 2019)
  • K191731 — Instylla Microcatheter (August 13, 2019)

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