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510(k) K100842

PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM by Hotspur Technologies — Product Code DXE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 2010
Date Received
March 25, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Embolectomy
Device Class
Class II
Regulation Number
870.5150
Review Panel
CV
Submission Type

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  • K101047 — PTA-DUO PTA BALLOON CATHETER (July 13, 2010)
  • K100840 — EMBO PLUS EMBOLECTOMY CATHETER (July 12, 2010)

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