EndoWave Connector clip

  • Model / Serial
    CIC Connector Clip Part Number: 700-4000; Lot numbers: 080324024, 080324025, 080324026, 080324027, 080325002, 080325003. EndoWave System Control Unit S/N: PT3B-001, PT3B-002, PT3B-004, PT3B-006, PT3B-007, PT3B-008, PT3B-009, PT3B-010, PT3B-011, PT3B-012, PT3B-013, PT3B-014, PT3B-017, PT3B-018, PT3B-020, PT3B-021, PT3B-022, PT3B-024, PT3B-025, PT3B-027, PT3B-029, PT3B-030, PT3B-031, PT3B-032, PT3B-033, PT3B-034, PT3B-035, PT3B-037, PT3B-038, PT3B-040, PT3B-041, PT3B-042, PT3B-043, PT3B-044, PT3B-045, PT3B-046, PT3B-047, PT3B-049, PT3B-050, PT3B-051, PT3B-052, PT3B-057, PT3B-058, PT3B-059, PT3B-060, PT3B-062, PT3B-063, PT3B-064, PT3B-065, PT3B-066, PT3B-067, PT3B-068, PT3B-070, PT3B-071, PT3B-072, PT3B-073, PT3B-074, PT3B-075, PT3B-076, PT3B-078, PT3B-079, PT3B-080, PT3B-082, PT3B-084, PT3B-085, PT3B-087, PT3B-088, PT3B-089, PT3B-090, PT3B-091, PT3B-093, PT3B-094, PT3B-095, PT3B-096, PT3B-097, PT3B-098, PT3B-099, PT3B-100, PT3B-102, PT3B-103, PT3B-104, PT3B-108, PT3B-109, PT3B-110, PT3B-111, PT3B-112, PT3B-113, PT3B-114, PT3B-115, PT3B-118, PT3B-119, PT3B-121, PT3B-123, PT3B-124, PT3B-127, PT3B-128, PT3B-130, PT3B-131, PT3B-132, PT3B-133, PT3B-135, PT3B-137, PT3B-138, PT3B-139, PT3B-140, PT3B-141, PT3B-143, PT3B-145, PT3B-146, PT3B-147, PT3B-148, PT3B-150, PT3B-151, PT3B-152, PT3B-153, PT3B-154, PT3B-155, PT3B-156, PT3B-157, PT3B-158, PT3B-159, PT3B-163, PT3B-164, PT3B-165, PT3B-168, PT3B-169, PT3B-172, PT3B-173, PT3B-174, PT3B-175, PT3B-176, PT3B-177, PT3B-178, PT3B-180, PT3B-181, PT3B-183, PT3B-186, PT3B-188, PT3B-192, PT3B-193, PT3B-195, PT3B-196, PT3B-197, PT3B-199, PT3B-201, PT3B-202, PT3B-204, PT3B-205, PT3B-206, PT3B-207, PT3B-208, PT3B-210, PT3B-211, PT3B-212, PT3B-214, PT3B-215, PT3B-217, PT3B-218, PT3B-219, PT3B-221, PT3B-253, PT3B-254, PT3B-255, PT3B-256, PT3B-257, PT3B-258, PT3B-259, PT3B-260, PT3B-261, PT3B-262, PT3B-263, PT3B-264, PT3B-265, PT3B-266, PT3B-267, PT3B-268, PT3B-269, PT3B-270, PT3B-271, PT3B-273, PT3B-274, PT3B-275, PT3B-276, PT3B-280, PT3B-285, PT3B-286, PT3B-287, PT3B-288, PT3B-289, PT3B-291, PT3B-292, PT3B-294, PT3B-295, PT3B-297, PT3B-298, PT3B-308, PT3B-310, PT3B-311, PT3B-312, PT3B-313, PT3B-314, PT3B-315, PT3B-316, PT3B-319, PT3B-320, PT3B-321, PT3B-323, PT3B-326, PT3B-328, PT3B-329, PT3B-332, PT3B-333, PT3B-334, PT3B-335, PT3B-337, PT3B-338, PT3B-339, and PT3B-344.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Class II Recall - Nationwide
  • Product Description
    Infusion System. EKOS EndoWave Infusion System. EKOS EndoWave Infusion System Drug Delivery Catheter with Ultrasound Core. Labeled as Sterile, Single Use Only. Connector clip is CIC Connector Clip. The infusion system is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytes, into the peripheral vasculature.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    EKOS Corporation, 11911 N Creek Pkwy S, Bothell WA 98011-8809
  • Manufacturer Parent Company (2017)
  • Source
    USFDA