Question 1

Who is the manufacturer of FELT, SURGICAL DACRON?

Accepted Answer

Meadox Medicals, Div. Boston Scientific Corp. filed the 510(k) submission for FELT, SURGICAL DACRON (K760516).

Question 2

What is the FDA product code for FELT, SURGICAL DACRON?

Accepted Answer

DXZ. It is classified under 21 CFR 870.3470 as a Class 2 device in the Cardiovascular panel.

Question 3

When was FELT, SURGICAL DACRON cleared by the FDA?

Accepted Answer

Jan 5, 1977 (decision: SESE).

Question 4

What is the regulatory pathway for FELT, SURGICAL DACRON?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like FELT, SURGICAL DACRON?

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	K760516
Device Name	FELT, SURGICAL DACRON
Applicant	Meadox Medicals, Div. Boston Scientific Corp.
Product Code	DXZ · Cardiovascular
Decision Date	Jan 5, 1977
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.3470
Device Class	Class 2

FELT, SURGICAL DACRON

Device Facts

Regulatory Classification

Identification