Cleared Traditional

K761050 - HEPARIN PUMP (FDA 510(k) Clearance)

K761050 · Dws, Inc. · Gastroenterology & Urology device

Dec 1976

Decision

45d

Days

Class 2

Risk

K761050 is an FDA 510(k) clearance for the HEPARIN PUMP. This device is classified as a Pump, Blood, Extra-luminal (Class II - Special Controls, product code FIR).

Submitted by Dws, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 30, 1976, 45 days after receiving the submission on November 15, 1976.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.

Submission Details

510(k) Number	K761050 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 15, 1976
Decision Date	December 30, 1976
Days to Decision	45 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	—