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510(k) K092361

REEF HP 0.035 OTW PTA BALLOON DILATATION CATHETER by Invatec S.P.A. — Product Code LIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 2009
Date Received
August 4, 2009
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 Invatec S.P.A.

  • K100921 — ADMIRAL XTREME PTA BALLOON DILATATION CATHETER (April 30, 2010)
  • K092352 — SCUBA BILIARY STENT SYSTEM (March 16, 2010)
  • K092177 — MO.MA ULTRA PROXIMAL CEREBRAL PROTECTION DEVICE, MODEL MUS0130069X6 (October 15, 2009)

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