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510(k) K080364

FINDRWIRZ GUIDE WIRE SYSTEM by Sentreheart, Inc. — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 2008
Date Received
February 11, 2008
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 Sentreheart, Inc.

  • K153096 — LARIAT RS Suture Delivery Device (November 25, 2015)
  • K142241 — LARIAT sulture Delivery Device (September 12, 2014)
  • K090385 — LARIAT II SUTURE DELIVERY DEVICE (May 6, 2009)
  • K070126 — OCCLUSION BALLOON CATHETER (February 8, 2008)
  • K060721 — LARIAT LOOP APPLICATOR (June 2, 2006)

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