Question 1

Who is the manufacturer of INTRALUMINAL ARTERY STRIPPER?

Accepted Answer

Omni-Tract Surgical, Div. Minn. Scientific, Inc. filed the 510(k) submission for INTRALUMINAL ARTERY STRIPPER (K913803).

Question 2

What is the FDA product code for INTRALUMINAL ARTERY STRIPPER?

Accepted Answer

DWX. It is classified under 21 CFR 870.4875 as a Class 2 device in the Cardiovascular panel.

Question 3

When was INTRALUMINAL ARTERY STRIPPER cleared by the FDA?

Accepted Answer

Apr 24, 1992 (decision: SESE).

Question 4

What is the regulatory pathway for INTRALUMINAL ARTERY STRIPPER?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like INTRALUMINAL ARTERY STRIPPER?

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	K913803
Device Name	INTRALUMINAL ARTERY STRIPPER
Applicant	Omni-Tract Surgical, Div. Minn. Scientific, Inc.
Product Code	DWX · Cardiovascular
Decision Date	Apr 24, 1992
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.4875
Device Class	Class 2

INTRALUMINAL ARTERY STRIPPER

Device Facts

Regulatory Classification

Identification