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510(k) K101047

PTA-DUO PTA BALLOON CATHETER by Hotspur Technologies — Product Code LIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2010
Date Received
April 14, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Angioplasty, Peripheral, Transluminal
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

Other clearances by Hotspur Technologies

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  • K100842 — PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM (July 12, 2010)

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