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510(k) K153096

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 2015
Date Received
October 26, 2015
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.

  • K142241 — LARIAT sulture Delivery Device (September 12, 2014)
  • 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)

Other clearances for product code GAT

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  • K253145 — Pre-Sutured Tendon (October 22, 2025)
  • K253024 — ProZip Knotless Implant (October 16, 2025)
  • K252225 — PowerKnot High Strength Sutures (September 12, 2025)
  • K252201 — HS Fiber (August 13, 2025)
  • K242201 — HyperSuture White/Green Extension Line (March 27, 2025)
  • K241376 — HyperSuture All Blue Extension Line (August 9, 2024)
  • K234079 — HyperSuture Extension Line (May 10, 2024)
  • K231163 — HS Fiber Sutures (January 5, 2024)
  • K230311 — HyperSuture (November 24, 2023)