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510(k) DEN090007

BIO-SEAL LUNG BIOPSY TRACT SYSTEM by Angiotech — Product Code OMT

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
December 19, 2012
Date Received
April 17, 2009
Clearance Type
Post-NSE
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Absorbable Lung Biopsy Plug
Device Class
Class II
Regulation Number
878.4755
Review Panel
AN
Submission Type

A pre-formed (polymerized) absorbable lung biopsy plug is intended to provide accuracy in marking a biopsy location for visualization during surgical resection and closure of pleural punctures associated with percutaneous, transthoracic needle lung biopsies. Upon, deployment into the biopsy tract, the plug expands to fill the biopsy void and remains in place until resorbed.

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  • K113744 — QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIOXANONE) (February 1, 2012)
  • K113800 — QUILL QUADRAHELIX TISSUE-CLOSURE DEVICE (January 20, 2012)
  • K073672 — SKATER BILIARY CATHETER (January 24, 2008)
  • K070610 — SKATER BILIARY CATHETER (June 21, 2007)

Other clearances for product code OMT

  • K243722 — Pre-B Seal Lung Biopsy Plug System - 15cm Model (FG0001); Pre-B Seal Lung Biopsy (April 8, 2025)