Question 1

Who is the manufacturer of MODEL 611101 CONTRAST INJECTION DEVICE?

Accepted Answer

Medtronic Versaflex, Inc. filed the 510(k) submission for MODEL 611101 CONTRAST INJECTION DEVICE (K890898).

Question 2

What is the FDA product code for MODEL 611101 CONTRAST INJECTION DEVICE?

Accepted Answer

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

Question 3

When was MODEL 611101 CONTRAST INJECTION DEVICE cleared by the FDA?

Accepted Answer

Apr 12, 1989 (decision: SESE).

Question 4

What is the regulatory pathway for MODEL 611101 CONTRAST INJECTION DEVICE?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like MODEL 611101 CONTRAST INJECTION DEVICE?

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	K890898
Device Name	MODEL 611101 CONTRAST INJECTION DEVICE
Applicant	Medtronic Versaflex, Inc.
Product Code	DXT · Cardiovascular
Decision Date	Apr 12, 1989
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1650
Device Class	Class 2

MODEL 611101 CONTRAST INJECTION DEVICE

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Regulatory Classification

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