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510(k) K173709

Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm by Inneuroco, Inc. — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 2018
Date Received
December 4, 2017
Clearance Type
Special
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.

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  • K172167 — Zenith Flex System (April 19, 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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