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510(k) K213949

VASSALLO GT 018 Floppy by Filmecc Co., Ltd. — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2022
Date Received
December 17, 2021
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

Other clearances by Filmecc Co., Ltd.

  • K223432 — Vassallo GT 018 Hybrid (March 9, 2023)
  • K222631 — VASSALLO GT EXT (October 26, 2022)
  • K203529 — VASSALLO GT Hybrid (May 4, 2021)
  • K203533 — VASSALLO GT (April 21, 2021)

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