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510(k) K230377

CROSSLEAD Penetration Peripheral Guide Wire by Asahi Intecc Co., Ltd. — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 2023
Date Received
February 13, 2023
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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