Cleared Traditional Expedited

CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS

K991594 · Sangstat Medical Corp. · Gastroenterology & Urology

Aug 1999

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K991594 is an FDA 510(k) clearance for the CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS, a System And Accessories, Isolated Heart, Transport And Preservation (Class II — Special Controls, product code MSB), submitted by Sangstat Medical Corp. (Fremont, US). The FDA issued a Cleared decision on August 5, 1999, 90 days after receiving the submission on May 7, 1999. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5880.

Submission Details

510(k) Number	K991594 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 07, 1999
Decision Date	August 05, 1999
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	MSB — System And Accessories, Isolated Heart, Transport And Preservation
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.5880