Cleared Traditional

K781184 - INFUSION SET, VENOTHIN 19
(FDA 510(k) Clearance)

K781184 · Venospital, Inc. · General Hospital

Aug 1978

Decision

27d

Days

Class 2

Risk

K781184 is an FDA 510(k) clearance for the INFUSION SET, VENOTHIN 19. This device is classified as a Set, Administration, Intravascular (Class II — Special Controls, product code FPA).

Submitted by Venospital, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 10, 1978, 27 days after receiving the submission on July 14, 1978.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K781184 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 14, 1978
Decision Date	August 10, 1978
Days to Decision	27 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	—