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510(k) K000001

WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM by Boston Scientific Scimed, Inc. — Product Code JCT

K000001 is an FDA 510(k) premarket notification submitted by Boston Scientific Scimed, Inc. for the device "WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM". The FDA issued a decision of Substantially Equivalent on June 5, 2000. The device falls under product code JCT (Prosthesis, Tracheal, Expandable), a Class II device regulated under 21 CFR 878.3720. Boston Scientific Scimed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 2000
Date Received
January 3, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Tracheal, Expandable
Device Class
Class II
Regulation Number
878.3720
Review Panel
AN
Submission Type

Other clearances by Boston Scientific Scimed, Inc.

  • K041727 — MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456 (July 23, 2004)
  • K030617 — PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE (May 21, 2003)
  • K024048 — MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM (January 6, 2003)
  • K021735 — BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER (August 8, 2002)
  • K021901 — WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (July 9, 2002)
  • K012822 — MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY SYSTEM, (October 24, 2001)
  • K012216 — NIROYAL BILIARY PREMOUNTED STENT SYSTEM (August 17, 2001)
  • K000743 — BOSTON SCIENTIFIC SCIMED ATLANTIS CORONARY IMAGING CATHETER, MODEL C4020 (September 6, 2000)
  • K000956 — MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS (April 21, 2000)
  • K993232 — WALLSTENT BILIARY ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM (December 30, 1999)

Other clearances for product code JCT

  • K230269 — Ultraflex™ Tracheobronchial Stent System (July 14, 2023)
  • K220424 — Through the Scope Tracheal Stent System (July 8, 2022)
  • K212403 — Tracheal Stent System (Y-Shaped) (October 30, 2021)
  • K202204 — Tracheal Stent System (September 1, 2021)
  • K201342 — HANAROSTENT Trachea/Bronchium (CCC) (December 31, 2020)
  • K181200 — AEROmini Tracheobronchial Stent System (September 21, 2018)
  • K152842 — WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOB (May 19, 2016)
  • K140382 — AEROMINI TRACHEOBRONCHIAL STENT TECHNOLOGY (November 25, 2014)
  • K140472 — BONASTENT TRACHEAL / BRONCHIAL (October 17, 2014)
  • K141584 — ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM (October 16, 2014)

FDA data resources