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510(k) K992863

LEAD STYLET,MODELS 6505,6506,6507,6508 by Guidant Corp. — Product Code DRB

K992863 is an FDA 510(k) premarket notification submitted by Guidant Corp. for the device "LEAD STYLET,MODELS 6505,6506,6507,6508". The FDA issued a decision of Substantially Equivalent on November 12, 1999. The device falls under product code DRB (Stylet, Catheter), a Class II device regulated under 21 CFR 870.1380. Guidant Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 1999
Date Received
August 25, 1999
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 Guidant Corp.

  • K061865 — FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05 (July 27, 2006)
  • K061453 — HI-TORQUE WHISPER VIEW GUIDE WIRE (June 22, 2006)
  • K042908 — RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM (November 12, 2004)
  • K042218 — ACCUNET EMBOLIC PROTECTION SYSTEM, RX ACCUNET EMBOLIC PROTECTION SYSTEM (August 31, 2004)
  • K033834 — OMNILINK .018 BILIARY STENT SYSTEM (January 2, 2004)
  • K033393 — ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM (November 10, 2003)
  • K031678 — HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING (August 26, 2003)
  • K031459 — RAPIDO CUT-AWAY CUTTER (July 23, 2003)
  • K031398 — IS-1 HEMOSTASIS VALVE, MODEL 6799 (May 20, 2003)
  • K030512 — GUIDANT VASOVIEW ENDOSCOPIC VESSEL HARVESTING SYSTEM (May 14, 2003)

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