Question 1

Who is the manufacturer of PACEMAKER, OVALITH-D CARDIAC?

Accepted Answer

Caratomic filed the 510(k) submission for PACEMAKER, OVALITH-D CARDIAC (K790566).

Question 2

What is the FDA product code for PACEMAKER, OVALITH-D CARDIAC?

Accepted Answer

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

Question 3

When was PACEMAKER, OVALITH-D CARDIAC cleared by the FDA?

Accepted Answer

Mar 19, 1979 (decision: SESP).

Question 4

What is the regulatory pathway for PACEMAKER, OVALITH-D CARDIAC?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like PACEMAKER, OVALITH-D CARDIAC?

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	K790566
Device Name	PACEMAKER, OVALITH-D CARDIAC
Applicant	Caratomic
Product Code	DXY · Cardiovascular
Decision Date	Mar 19, 1979
Decision	SESP
Submission Type	Traditional
Regulation	21 CFR 870.3610
Device Class	Class 3

PACEMAKER, OVALITH-D CARDIAC

Device Facts

Regulatory Classification

Identification