Cleared Traditional

CARDIOFLOW 100 HEMOCONCENTRATOR/PREPARATION KIT

K883307 · Hospal Medical Corp. · Gastroenterology & Urology

Oct 1988

Decision

69d

Days

Class 2

Risk

About This 510(k) Submission

K883307 is an FDA 510(k) clearance for the CARDIOFLOW 100 HEMOCONCENTRATOR/PREPARATION KIT, a Dialyzer, High Permeability With Or Without Sealed Dialysate System (Class II — Special Controls, product code KDI), submitted by Hospal Medical Corp. (Edison, US). The FDA issued a Cleared decision on October 12, 1988, 69 days after receiving the submission on August 4, 1988. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.

Submission Details

510(k) Number	K883307 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 04, 1988
Decision Date	October 12, 1988
Days to Decision	69 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	—

Device Classification

Product Code	KDI — Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.5860