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510(k) K210808

Instylla Microcatheter 1.2 by Instylla, Inc. — Product Code KRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 2021
Date Received
March 17, 2021
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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  • K202544 — Instylla Delivery Kit (January 7, 2021)
  • K200744 — Instylla Microcatheter (April 21, 2020)
  • K191659 — Instylla Delivery Kit (October 10, 2019)
  • K191731 — Instylla Microcatheter (August 13, 2019)

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