Question 1

Who is the manufacturer of CONTRAST INJECTION LINES?

Accepted Answer

B.Braun Medical, Inc. filed the 510(k) submission for CONTRAST INJECTION LINES (K960674).

Question 2

What is the FDA product code for CONTRAST INJECTION LINES?

Accepted Answer

DXT. It is classified under 21 CFR 870.1650 as a Class 2 device in the Cardiovascular panel.

Question 3

When was CONTRAST INJECTION LINES cleared by the FDA?

Accepted Answer

Sep 19, 1996 (decision: SESE).

Question 4

What is the regulatory pathway for CONTRAST INJECTION LINES?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like CONTRAST INJECTION LINES?

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	K960674
Device Name	CONTRAST INJECTION LINES
Applicant	B.Braun Medical, Inc.
Product Code	DXT · Cardiovascular
Decision Date	Sep 19, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1650
Device Class	Class 2

CONTRAST INJECTION LINES

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