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510(k) K241702

CROSSLEAD 0.014inch by Asahi Intecc Co., Ltd. — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 2025
Date Received
June 13, 2024
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

Other clearances by Asahi Intecc Co., Ltd.

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  • K242597 — CROSSLEAD 0.018inch (March 5, 2025)
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  • K241510 — CROSSLEAD Tracker (August 14, 2024)
  • K241158 — ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3 (June 25, 2024)

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  • K250552 — Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire (July 25, 2025)
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