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510(k) K072864

ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM by St. Jude Medical, Cardiac Rhythm Management Divisi — Product Code DRB

K072864 is an FDA 510(k) premarket notification submitted by St. Jude Medical, Cardiac Rhythm Management Divisi for the device "ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM". The FDA issued a decision of Substantially Equivalent on March 13, 2008. The device falls under product code DRB (Stylet, Catheter), a Class II device regulated under 21 CFR 870.1380. St. Jude Medical, Cardiac Rhythm Management Divisi has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2008
Date Received
October 5, 2007
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 St. Jude Medical, Cardiac Rhythm Management Divisi

  • K122090 — SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (November 15, 2012)
  • K120296 — CPS DIRECT MEDIGUIDE ENABLED OUTER CATHETER (May 11, 2012)
  • K120298 — CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE (May 8, 2012)
  • K111943 — AGILLS PF DELIVERY SYSTEM (September 29, 2011)
  • K103250 — CPS DIRECT SL II SLITTABLE OUTER CATHETER (January 19, 2011)
  • K093858 — PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053A (April 2, 2010)
  • K092075 — CPS DIRECT SL II SLITTABLE OUTER CATHETER, MODELS DS2C001, DS2C002, DS2C003, DS2 (August 7, 2009)
  • K090613 — CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59, DS2NO23-59, (July 1, 2009)
  • K080924 — MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151 (April 30, 2008)

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)
  • K053019 — ACUITY STEERABLE STYLET ACCESSORY (March 3, 2006)
  • K052965 — EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832. (February 13, 2006)
  • K043401 — SPECTRANETICS LLD CS, MODEL 518-039 (March 16, 2005)

FDA data resources