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510(k) K193126

HI-TORQUE InfilTrac Guide Wire Family by Abbott Vascular — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2019
Date Received
November 12, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wire, Guide, Catheter
Device Class
Class II
Regulation Number
870.1330
Review Panel
CV
Submission Type

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  • K172073 — Hi-Torque Command 18 Guide Wire (August 25, 2017)
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