Cleared Special

NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693

K072024 · Nipro Medical Corp. · Gastroenterology & Urology

Oct 2007

Decision

72d

Days

Class 2

Risk

About This 510(k) Submission

K072024 is an FDA 510(k) clearance for the NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693, a Set, Tubing, Blood, With And Without Anti-regurgitation Valve (Class II — Special Controls, product code FJK), submitted by Nipro Medical Corp. (Miami, US). The FDA issued a Cleared decision on October 4, 2007, 72 days after receiving the submission on July 24, 2007. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.

Submission Details

510(k) Number	K072024 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 24, 2007
Decision Date	October 04, 2007
Days to Decision	72 days
Submission Type	Special
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	FJK — Set, Tubing, Blood, With And Without Anti-regurgitation Valve
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.5820