Question 1

Who is the manufacturer of TEMPORARY CARDIAC PACING WIRE?

Accepted Answer

ETHICON, Inc. filed the 510(k) submission for TEMPORARY CARDIAC PACING WIRE (K781002).

Question 2

What is the FDA product code for TEMPORARY CARDIAC PACING WIRE?

Accepted Answer

LDF. It is classified under 21 CFR 870.3680 as a Class 2 device in the Cardiovascular panel.

Question 3

When was TEMPORARY CARDIAC PACING WIRE cleared by the FDA?

Accepted Answer

Dec 4, 1978 (decision: SESE).

Question 4

What is the regulatory pathway for TEMPORARY CARDIAC PACING WIRE?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like TEMPORARY CARDIAC PACING WIRE?

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	K781002
Device Name	TEMPORARY CARDIAC PACING WIRE
Applicant	ETHICON, Inc.
Product Code	LDF · Cardiovascular
Decision Date	Dec 4, 1978
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.3680
Device Class	Class 2

TEMPORARY CARDIAC PACING WIRE

Device Facts

Regulatory Classification

Identification