GLIDERXTREME PTA BALLON CATHETER (OVER THE WIRE) 0.018 GUIDE WIRE 6100-XXXXX, 6100CB-XXXX (K112281) — FDA 510(k) Clearance | Predicase

K-number	K112281
Device name	GLIDERXTREME PTA BALLON CATHETER (OVER THE WIRE) 0.018 GUIDE WIRE 6100-XXXXX, 6100CB-XXXX
Applicant	Trireme Medical, Inc.
Product code	DQY
Device class	Class II
Decision date	Aug 17, 2011
Decision	Substantially Equivalent
Regulation	870.1250

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View the full FDA submission: accessdata.fda.gov

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