Question 1

Who is the manufacturer of FOCUS J81F, J83F, J41F, J43F PACING LEADS?

Accepted Answer

Ela Medical, Inc. filed the 510(k) submission for FOCUS J81F, J83F, J41F, J43F PACING LEADS (K896742).

Question 2

What is the FDA product code for FOCUS J81F, J83F, J41F, J43F PACING LEADS?

Accepted Answer

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

Question 3

When was FOCUS J81F, J83F, J41F, J43F PACING LEADS cleared by the FDA?

Accepted Answer

Jul 17, 1990 (decision: SESE).

Question 4

What is the regulatory pathway for FOCUS J81F, J83F, J41F, J43F PACING LEADS?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like FOCUS J81F, J83F, J41F, J43F PACING LEADS?

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	K896742
Device Name	FOCUS J81F, J83F, J41F, J43F PACING LEADS
Applicant	Ela Medical, Inc.
Product Code	DTB · Cardiovascular
Decision Date	Jul 17, 1990
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.3680
Device Class	Class 3

FOCUS J81F, J83F, J41F, J43F PACING LEADS

Device Facts

Regulatory Classification

Identification