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510(k) K220331

091 Balloon Guide Catheter by Inneuroco, Inc. — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2022
Date Received
February 4, 2022
Clearance Type
Traditional
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 Inneuroco, Inc.

  • K232260 — Thinline Sheath Introducer (September 27, 2023)
  • K190338 — 046 Zenith Flex (August 2, 2019)
  • K181354 — 074 Zenith Flex System (October 25, 2018)
  • K172167 — Zenith Flex System (April 19, 2018)
  • K173709 — Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm (January 26, 2018)
  • K172468 — 091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm (December 6, 2017)
  • K171672 — 065 Zenith, 074 Zenith (October 19, 2017)
  • K161262 — Super Distal Access (SDA) (September 19, 2016)

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