Question 1

Who is the manufacturer of MICROFLUSH?

Accepted Answer

Medex, Inc. filed the 510(k) submission for MICROFLUSH (K770432).

Question 2

What is the FDA product code for MICROFLUSH?

Accepted Answer

KRA. It is classified under 21 CFR 870.1210 as a Class 2 device in the Cardiovascular panel.

Question 3

When was MICROFLUSH cleared by the FDA?

Accepted Answer

Mar 16, 1977 (decision: SESE).

Question 4

What is the regulatory pathway for MICROFLUSH?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like MICROFLUSH?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K770432
Device Name	MICROFLUSH
Applicant	Medex, Inc.
Product Code	KRA · Cardiovascular
Decision Date	Mar 16, 1977
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1210
Device Class	Class 2

MICROFLUSH

Device Facts

Regulatory Classification

Identification