Question 1

Who is the manufacturer of CCS IMPLANTABLE MAESTRO SERIES 100 CARDIAC PACEMA?

Accepted Answer

Cardiac Control Systems, Inc. filed the 510(k) submission for CCS IMPLANTABLE MAESTRO SERIES 100 CARDIAC PACEMA (K852435).

Question 2

What is the FDA product code for CCS IMPLANTABLE MAESTRO SERIES 100 CARDIAC PACEMA?

Accepted Answer

DXY. It is classified under 21 CFR 870.3610 as a Class 3 device in the Cardiovascular panel.

Question 3

When was CCS IMPLANTABLE MAESTRO SERIES 100 CARDIAC PACEMA cleared by the FDA?

Accepted Answer

Aug 6, 1985 (decision: SESE).

Question 4

What is the regulatory pathway for CCS IMPLANTABLE MAESTRO SERIES 100 CARDIAC PACEMA?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like CCS IMPLANTABLE MAESTRO SERIES 100 CARDIAC PACEMA?

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	K852435
Device Name	CCS IMPLANTABLE MAESTRO SERIES 100 CARDIAC PACEMA
Applicant	Cardiac Control Systems, Inc.
Product Code	DXY · Cardiovascular
Decision Date	Aug 6, 1985
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.3610
Device Class	Class 3

CCS IMPLANTABLE MAESTRO SERIES 100 CARDIAC PACEMA

Device Facts

Regulatory Classification

Identification