Question 1

Who is the manufacturer of MEDTRONIC MODEL 69575?

Accepted Answer

Medtronic Vascular filed the 510(k) submission for MEDTRONIC MODEL 69575 (K800944).

Question 2

What is the FDA product code for MEDTRONIC MODEL 69575?

Accepted Answer

DTB. It is classified under 21 CFR 870.3680 as a Class 3 device in the Cardiovascular panel.

Question 3

When was MEDTRONIC MODEL 69575 cleared by the FDA?

Accepted Answer

Sep 26, 1980 (decision: SESE).

Question 4

What is the regulatory pathway for MEDTRONIC MODEL 69575?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like MEDTRONIC MODEL 69575?

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	K800944
Device Name	MEDTRONIC MODEL 69575
Applicant	Medtronic Vascular
Product Code	DTB · Cardiovascular
Decision Date	Sep 26, 1980
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.3680
Device Class	Class 3

MEDTRONIC MODEL 69575

Device Facts

Regulatory Classification

Identification