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510(k) K142241

LARIAT sulture Delivery Device by Sentreheart, Inc. — Product Code GAT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2014
Date Received
August 13, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class
Class II
Regulation Number
878.5000
Review Panel
SU
Submission Type

Other clearances by Sentreheart, Inc.

  • K153096 — LARIAT RS Suture Delivery Device (November 25, 2015)
  • K090385 — LARIAT II SUTURE DELIVERY DEVICE (May 6, 2009)
  • K080364 — FINDRWIRZ GUIDE WIRE SYSTEM (August 11, 2008)
  • K070126 — OCCLUSION BALLOON CATHETER (February 8, 2008)
  • K060721 — LARIAT LOOP APPLICATOR (June 2, 2006)

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  • K252225 — PowerKnot High Strength Sutures (September 12, 2025)
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  • K234079 — HyperSuture Extension Line (May 10, 2024)
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