Cleared Special

MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING

K131517 · Medrad, Inc. / Bayer Medical Care, Inc. · General Hospital
Aug 2013
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K131517 is an FDA 510(k) clearance for the MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING, a Tubing, Fluid Delivery (Class II — Special Controls, product code FPK), submitted by Medrad, Inc. / Bayer Medical Care, Inc. (Indianola, US). The FDA issued a Cleared decision on August 2, 2013, 66 days after receiving the submission on May 28, 2013. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K131517 FDA.gov
FDA Decision Cleared SESE
Date Received May 28, 2013
Decision Date August 02, 2013
Days to Decision 66 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FPK — Tubing, Fluid Delivery
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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