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510(k) K193194

CrossTorq 14 Guidewire by Scientia Cardio Access, LLC — Product Code DQX

K193194 is an FDA 510(k) premarket notification submitted by Scientia Cardio Access, LLC for the device "CrossTorq 14 Guidewire". The FDA issued a decision of Substantially Equivalent on Dec 13, 2019. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 13, 2019
Date Received
Nov 19, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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FDA data resources