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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K180169

EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071 ID, 137cm Length, EagleRay Access Catheter, 0.055 ID, 137cm Length, EagleRay Access Catheter, 0.045 ID, 144cm Length, EagleRay Access Catheter, 0.035 ID, 158cm Length · Imperative Care, Inc. · decided 2018-08-08 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
TracStar™ Large Distal PlatformICAC088095IMPERATIVE CARE, INC.DQY00812212030122
ZOOM™ 88-T Large Distal PlatformICTC088100IMPERATIVE CARE, INC.DQY00812212030160
TracStar™ Large Distal PlatformICAC088080IMPERATIVE CARE, INC.DQY00812212030108
TracStar™ Large Distal PlatformICAC088090IMPERATIVE CARE, INC.DQY00812212030115
ZOOM™ 88 Large Distal PlatformICFC088100IMPERATIVE CARE, INC.DQY00812212030146
ZOOM™ 88 Large Distal PlatformICFC088110IMPERATIVE CARE, INC.DQY00812212030153
TRX™ Long SheathICAC088090IMPERATIVE CARE, INC.DQY00812212030016
TracStar™ Large Distal PlatformICAC088100IMPERATIVE CARE, INC.DQY00812212030023
TracStar™ Large Distal PlatformICAC088110IMPERATIVE CARE, INC.DQY00812212030030
TracStar™ Large Distal PlatformICAC088105IMPERATIVE CARE, INC.DQY00812212030139
TRX™ Long SheathICAC088080IMPERATIVE CARE, INC.DQY00812212030009