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510(k) K002534

EUPALAMUS DEFLECTABLE STYLET, MODEL 01545 by Eupalamus, LLC — Product Code DRB

K002534 is an FDA 510(k) premarket notification submitted by Eupalamus, LLC for the device "EUPALAMUS DEFLECTABLE STYLET, MODEL 01545". The FDA issued a decision of Substantially Equivalent on October 18, 2000. The device falls under product code DRB (Stylet, Catheter), a Class II device regulated under 21 CFR 870.1380.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2000
Date Received
August 16, 2000
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

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  • 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