Who is the manufacturer of MEDTRONIC MODEL 5328 PROGRAM-STIMULATOR?

Medtronic Vascular filed the 510(k) submission for MEDTRONIC MODEL 5328 PROGRAM-STIMULATOR (K851091).

What is the FDA product code for MEDTRONIC MODEL 5328 PROGRAM-STIMULATOR?

JOQ. It is classified under 21 CFR 870.1750 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for MEDTRONIC MODEL 5328 PROGRAM-STIMULATOR?

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

Who can help prepare an FDA 510(k) submission like MEDTRONIC MODEL 5328 PROGRAM-STIMULATOR?

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.

MEDTRONIC MODEL 5328 PROGRAM-STIMULATOR

K851091 · Medtronic Vascular · JOQ · Apr 16, 1985 · Cardiovascular

Device Facts

Record ID	K851091
Device Name	MEDTRONIC MODEL 5328 PROGRAM-STIMULATOR
Applicant	Medtronic Vascular
Product Code	JOQ · Cardiovascular
Decision Date	Apr 16, 1985
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1750
Device Class	Class 2

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