510(k) K240997

Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire by ABBOTT MEDICAL — Product Code DQX

K240997 is an FDA 510(k) premarket notification submitted by ABBOTT MEDICAL for the device "Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire". The FDA issued a decision of Substantially Equivalent on November 6, 2024. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. ABBOTT MEDICAL has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2024
Date Received
April 11, 2024
Clearance Type
Traditional
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