Question 1

Who is the manufacturer of EQUINOX OCCLUSION BALLOON CATHETER/SYSTEM - (10MM BALLOON, 4 & 13 MM TIP), (15 MM BALLOON, 4 & 13 MM TIP), (20 MM BALLOO?

Accepted Answer

Micro Therapeutics, Inc. filed the 510(k) submission for EQUINOX OCCLUSION BALLOON CATHETER/SYSTEM - (10MM BALLOON, 4 & 13 MM TIP), (15 MM BALLOON, 4 & 13 MM TIP), (20 MM BALLOO (K001237).

Question 2

What is the FDA product code for EQUINOX OCCLUSION BALLOON CATHETER/SYSTEM - (10MM BALLOON, 4 & 13 MM TIP), (15 MM BALLOON, 4 & 13 MM TIP), (20 MM BALLOO?

Accepted Answer

MJN. It is classified under 21 CFR 870.4450 as a Class 2 device in the Cardiovascular panel.

Question 3

When was EQUINOX OCCLUSION BALLOON CATHETER/SYSTEM - (10MM BALLOON, 4 & 13 MM TIP), (15 MM BALLOON, 4 & 13 MM TIP), (20 MM BALLOO cleared by the FDA?

Accepted Answer

May 18, 2000 (decision: SESE).

Question 4

What is the regulatory pathway for EQUINOX OCCLUSION BALLOON CATHETER/SYSTEM - (10MM BALLOON, 4 & 13 MM TIP), (15 MM BALLOON, 4 & 13 MM TIP), (20 MM BALLOO?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like EQUINOX OCCLUSION BALLOON CATHETER/SYSTEM - (10MM BALLOON, 4 & 13 MM TIP), (15 MM BALLOON, 4 & 13 MM TIP), (20 MM BALLOO?

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	K001237
Device Name	EQUINOX OCCLUSION BALLOON CATHETER/SYSTEM - (10MM BALLOON, 4 & 13 MM TIP), (15 MM BALLOON, 4 & 13 MM TIP), (20 MM BALLOO
Applicant	Micro Therapeutics, Inc.
Product Code	MJN · Cardiovascular
Decision Date	May 18, 2000
Decision	SESE
Submission Type	Special
Regulation	21 CFR 870.4450
Device Class	Class 2

EQUINOX OCCLUSION BALLOON CATHETER/SYSTEM - (10MM BALLOON, 4 & 13 MM TIP), (15 MM BALLOON, 4 & 13 MM TIP), (20 MM BALLOO

Device Facts

Regulatory Classification

Identification