Cleared Traditional

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

K180169 · Imperative Care, Inc. · Neurology

Aug 2018

Decision

198d

Days

Class 2

Risk

About This 510(k) Submission

K180169 is an FDA 510(k) clearance for the 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, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Imperative Care, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on August 8, 2018, 198 days after receiving the submission on January 22, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K180169 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 22, 2018
Decision Date	August 08, 2018
Days to Decision	198 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF