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510(k) K161402

Bullfrog Micro-Infusion Device by Mercator Medsystems, Inc. — Product Code KRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 2016
Date Received
May 20, 2016
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 Mercator Medsystems, Inc.

  • K210339 — Bullfrog Micro-Infusion Device (August 2, 2021)
  • K153501 — Bullfrog Micro-Infusion Device (April 15, 2016)
  • K131401 — BLOWFISH TRANSBRONCHIAL MICRO-INFUSION CATHETER (July 2, 2013)
  • K062752 — MERCATOR MICROSYRINGE II INFUSION CATHETER (December 7, 2006)

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