Cleared Special

K092930: NEXUS INTRAVASCULAR TUBING SETS-PRE-PIERCED

K092930 · Nexus Medical, LLC · General Hospital

Mar 2010

Decision

169d

Days

Class 2

Risk

About This 510(k) Submission

K092930 is an FDA 510(k) clearance for the NEXUS INTRAVASCULAR TUBING SETS-PRE-PIERCED, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Nexus Medical, LLC (Lenexa, US). The FDA issued a Cleared decision on March 10, 2010, 169 days after receiving the submission on September 22, 2009. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K092930 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 22, 2009
Decision Date	March 10, 2010
Days to Decision	169 days
Submission Type	Special
Review Panel	General Hospital (HO)
Summary	Statement