Home / 510(k) Clearances / K993376

510(k) K993376

ENSTYLET MODELS EC0010, EC0020 by Endocardial Solutions, Inc. — Product Code DRB

K993376 is an FDA 510(k) premarket notification submitted by Endocardial Solutions, Inc. for the device "ENSTYLET MODELS EC0010, EC0020". The FDA issued a decision of Substantially Equivalent on January 5, 2000. The device falls under product code DRB (Stylet, Catheter), a Class II device regulated under 21 CFR 870.1380. Endocardial Solutions, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 2000
Date Received
October 7, 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 Endocardial Solutions, Inc.

  • K042493 — ENSITE SYSTEM, MODEL EE3000 (October 15, 2004)
  • K033211 — ENSITE SYSTEM (October 30, 2003)
  • K030129 — MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000 (April 22, 2003)
  • K012926 — MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000 (September 28, 2001)
  • K001437 — ENSITE 3000 SYSTEM, MODEL EE3000 (June 7, 2000)
  • K992479 — ENSITE 3000 SYSTEM (December 2, 1999)
  • K983456 — ENSITE 3000 SYSTEM (April 21, 1999)

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