Question 1

Who is the manufacturer of MICRO-GUIDE SYSTEM?

Accepted Answer

Catheter Research C/O Burditt, Bowles & Radzius filed the 510(k) submission for MICRO-GUIDE SYSTEM (K884337).

Question 2

What is the FDA product code for MICRO-GUIDE SYSTEM?

Accepted Answer

DRA. It is classified under 21 CFR 870.1280 as a Class 2 device in the Cardiovascular panel.

Question 3

When was MICRO-GUIDE SYSTEM cleared by the FDA?

Accepted Answer

Jan 5, 1989 (decision: SESE).

Question 4

What is the regulatory pathway for MICRO-GUIDE SYSTEM?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like MICRO-GUIDE SYSTEM?

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	K884337
Device Name	MICRO-GUIDE SYSTEM
Applicant	Catheter Research C/O Burditt, Bowles & Radzius
Product Code	DRA · Cardiovascular
Decision Date	Jan 5, 1989
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1280
Device Class	Class 2

MICRO-GUIDE SYSTEM

Device Facts

Regulatory Classification

Identification