Question 1

Who is the manufacturer of WIRE, GUIDE, CATHETER?

Accepted Answer

Lake Region Mfg., Inc. filed the 510(k) submission for WIRE, GUIDE, CATHETER (K850829).

Question 2

What is the FDA product code for WIRE, GUIDE, CATHETER?

Accepted Answer

DQY. It is classified under 21 CFR 870.1250 as a Class 2 device in the Cardiovascular panel.

Question 3

When was WIRE, GUIDE, CATHETER cleared by the FDA?

Accepted Answer

Jun 26, 1985 (decision: SESE).

Question 4

What is the regulatory pathway for WIRE, GUIDE, CATHETER?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like WIRE, GUIDE, CATHETER?

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	K850829
Device Name	WIRE, GUIDE, CATHETER
Applicant	Lake Region Mfg., Inc.
Product Code	DQY · Cardiovascular
Decision Date	Jun 26, 1985
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1250
Device Class	Class 2

WIRE, GUIDE, CATHETER

Device Facts

Regulatory Classification

Identification