EP Catheter

  • Modèle / numéro de série
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, MA, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, WI, and WV OUS: CANADA
  • Description du dispositif
    EP Catheter || Model #'s: || BIOD6-DR-005-RT || BIOD6-DR-010-RT || DAI401381 || DAI401449 || DAI401904 || DAI401915 and || EPT7003D || Intended for temporary use during electrophysiology studies for intracardiac sensing, recording, and stimulation.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Sterilmed Inc, 11400 73rd Ave N Ste 100, Osseo MN 55369-5562
  • Société-mère du fabricant (2017)
  • Source
    USFDA

4 dispositifs médicaux avec un nom similaire

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  • Modèle / numéro de série
    Serial numbers 2451387, 2484264, 2484471, 2486823, 2487380, 2488350, 2490592, 2490605, 2492930, 2494064, 2494067, 2495242, 2495335, 2495337, 2495339, 2500403, 2500911, 2510524, 2518512, 2523848, 2523849, 2523851, 2525678, 2528071, 2534854, 2534856, 2608429, 2609031, 2609102, 2609105, 2609106, 2609107, 2609985, 2610794,  2610802, 2614613, 2614847, 2614909, 2615094, 2615098, 2615099, 2615319, 2615646, 2615712, 2615722, 2615725, 2615937, 2615938, 2615940, 2615943, 2615952, 2615966, 2616087, 2616088, 2616089, 2616090, 2616212, 2617794, 2617920, 2617987, 2617999, 2618010, 2618258, 2618832, 2618837, 2618881, 2618884, 2618990, 2618992, 2618993, 2619615, 2619742, 2619744, 2619827, 2620937, 2620942,  2620945, 2621283, 2621384, 2621385, 2621387, 2621424, 2621425, 2621847, 2621860, 2621880, 2623972, 2623974, 2624006, 2624010, 2624113, 2624138, 2625427, 2625536, 2625550, 2625623, 2625625, 2626330, 2626348, 2626929, 2626966, 2626988, 2627596, 2627946, 2627948, 2627949, 2629162, 2629164, 2630084, 2630085, 2630087, 2630351, 2631186, 2631188, 2631189, 2631191, 2631680, 2632641,  2633968, 2634008, 2634252, 2634271, 2634596, 2634709, 2634815, 2634836, 2635075, 2635077, 2635342, 2635343, 2635867, 2635873, 2636658, 2636759, 2636906, 2636986, 2637009, 2637022, 2637023, 2637233, 2637234, 2637237, 2637239, 2637257, 2637308, 2637495, 2637497, 2640103, 2640106, 2640107, 2640118, 2640119, 2642853, 2643222, 2643426, 2643432, 2646002, 2647122, 2669947, 2693960,  2696255, 2705129, 2708915, 2708916, 2712736, 2712756, 2713556, 2713593, 2713595, and 2713596.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    USA (nationwide) Distribution was made to medical facilities in AZ, CA, CT, FL, GA, IL, KS, LA, MN, MO, OH, PA, TX, VT, WA, and Wi. Foreign distribution was made to Canada.
  • Description du dispositif
    Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters, Ref D134301, Sterile, Rx. || The Reprocessed 2515 NAV eco Variable Electrophysiology (EP) Catheters are indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. They are designed to obtain electrograms in the atrial regions of the heart. The Reprocessed 2515 NAV eco Variable EP Catheters provide location information when used with compatible CARTO EP Navigation Systems version 2.3 or higher.
  • Manufacturer
  • Modèle / numéro de série
    Serial numbers 2468846, 2468849, 2509029, 2489074, 2491174, 2500529, 2465989, and 2500528
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    USA (nationwide) Distribution was made to medical facilities in AZ, CA, CT, FL, GA, IL, KS, LA, MN, MO, OH, PA, TX, VT, WA, and Wi. Foreign distribution was made to Canada.
  • Description du dispositif
    Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters, Ref D134302, Sterile, Rx. || The Reprocessed 2515 NAV eco Variable Electrophysiology (EP) Catheters are indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. They are designed to obtain electrograms in the atrial regions of the heart. The Reprocessed 2515 NAV eco Variable EP Catheters provide location information when used with compatible CARTO EP Navigation Systems version 2.3 or higher.
  • Manufacturer