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510(k) K211898

ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20 by Asahi Intecc Co., Ltd. — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 2021
Date Received
June 21, 2021
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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