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510(k) K120298

CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE by St. Jude Medical, Cardiac Rhythm Management Divisi — Product Code DQX

K120298 is an FDA 510(k) premarket notification submitted by St. Jude Medical, Cardiac Rhythm Management Divisi for the device "CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE". The FDA issued a decision of Substantially Equivalent on May 8, 2012. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. 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
May 8, 2012
Date Received
January 31, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wire, Guide, Catheter
Device Class
Class II
Regulation Number
870.1330
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)
  • 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)
  • K072864 — ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM (March 13, 2008)

Other clearances for product code DQX

  • K253146 — Hyperdrive 35 Guidewire (September 18, 2026)
  • K261281 — CROSSLEAD Standard 035 and CROSSLEAD Stiff 035 (September 3, 2026)
  • K253667 — Accoat Guide Wire (July 14, 2026)
  • K261640 — Merit MAK Nitinol/Gold-Tungsten Guide Wire (July 13, 2026)
  • K254137 — InQwire Amplatz Guide Wire (May 22, 2026)
  • K260544 — FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40 (March 20, 2026)
  • K253746 — Enroute 0.014'' Transcarotid Guidewire (March 19, 2026)
  • K253262 — EmeryGlide™ (EG18008901) (March 6, 2026)
  • K253847 — Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) (January 31, 2026)
  • K251385 — InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQ (January 21, 2026)

FDA data resources