Cleared Traditional

K840305 - CATEGORY 1 CIRCULATORY SYSTEM DEVICE
(FDA 510(k) Clearance)

K840305 · Imm Enterprises , Ltd. · Cardiovascular

Apr 1984

Decision

90d

Days

Class 1

Risk

K840305 is an FDA 510(k) clearance for the CATEGORY 1 CIRCULATORY SYSTEM DEVICE. This device is classified as a Instruments, Surgical, Cardiovascular (Class I — General Controls, product code DWS).

Submitted by Imm Enterprises , Ltd. (Mchenry, US). The FDA issued a Cleared decision on April 23, 1984, 90 days after receiving the submission on January 24, 1984.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4500.

Submission Details

510(k) Number	K840305 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 24, 1984
Decision Date	April 23, 1984
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	—