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510(k) K090385

LARIAT II SUTURE DELIVERY DEVICE by Sentreheart, Inc. — Product Code GAT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2009
Date Received
February 17, 2009
Clearance Type
Traditional
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.

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  • K070126 — OCCLUSION BALLOON CATHETER (February 8, 2008)
  • K060721 — LARIAT LOOP APPLICATOR (June 2, 2006)

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