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510(k) K913543

THORACIC CATHETER STYLET by Intl. Medical Devices , Ltd. — Product Code DRB

K913543 is an FDA 510(k) premarket notification submitted by Intl. Medical Devices , Ltd. for the device "THORACIC CATHETER STYLET". The FDA issued a decision of Substantially Equivalent on October 4, 1991. The device falls under product code DRB (Stylet, Catheter), a Class II device regulated under 21 CFR 870.1380. Intl. Medical Devices , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1991
Date Received
August 9, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stylet, Catheter
Device Class
Class II
Regulation Number
870.1380
Review Panel
CV
Submission Type

Other clearances by Intl. Medical Devices , Ltd.

  • K913541 — NEO-THOR THORACOSTOMY KIT (April 9, 1992)
  • K913540 — PEDIA-THOR THORACOSTOMY KIT (April 9, 1992)
  • K913542 — THORACIC CATHETER WITH GUIDE (January 21, 1992)
  • K913539 — THORACIC CATHTER STYLET (January 21, 1992)
  • K862909 — RE-TRAKE WEISS EMERGENCY AIRWAY & THORACIC SYSTEM (September 9, 1986)
  • K850398 — NU-CATH EMERGENCY KIT (March 27, 1985)
  • K843785 — WISSS PEDIATRIC TRACH- TUBE W/OBTURATOR (October 23, 1984)
  • K842666 — NU-THOR THORACOSTOMY KIT (September 20, 1984)
  • K840925 — PEDIA-TRAKE CRICOTHYROTOMY KIT (May 2, 1984)
  • K820778 — RESPIRATION MONITOR 1000 (May 3, 1982)

Other clearances for product code DRB

  • K220280 — Arrow Stiffening Stylet (August 30, 2022)
  • K191469 — Biotronik Stylets (August 1, 2019)
  • K182660 — GaltTWS (May 30, 2019)
  • K170298 — Liberator Beacon Tip Locking Stylet (October 18, 2017)
  • K142116 — LLD EZ (August 12, 2014)
  • K090163 — STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078 (April 1, 2009)
  • K080924 — MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151 (April 30, 2008)
  • K072864 — ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM (March 13, 2008)
  • K053019 — ACUITY STEERABLE STYLET ACCESSORY (March 3, 2006)
  • K052965 — EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832. (February 13, 2006)

FDA data resources