510(k) K241702

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

K241702 is an FDA 510(k) premarket notification submitted by Asahi Intecc Co., Ltd. for the device "CROSSLEAD 0.014inch". The FDA issued a decision of Substantially Equivalent on February 6, 2025. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Asahi Intecc Co., Ltd. has at least 10 other 510(k) clearances on record.

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