Question 1

Who is the manufacturer of SURGISIS PERIPHERAL VASCULAR PATCH?

Accepted Answer

Cook Biotech, Inc. filed the 510(k) submission for SURGISIS PERIPHERAL VASCULAR PATCH (K001785).

Question 2

What is the FDA product code for SURGISIS PERIPHERAL VASCULAR PATCH?

Accepted Answer

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

Question 3

When was SURGISIS PERIPHERAL VASCULAR PATCH cleared by the FDA?

Accepted Answer

Dec 27, 2000 (decision: SESE).

Question 4

What is the regulatory pathway for SURGISIS PERIPHERAL VASCULAR PATCH?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like SURGISIS PERIPHERAL VASCULAR PATCH?

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	K001785
Device Name	SURGISIS PERIPHERAL VASCULAR PATCH
Applicant	Cook Biotech, Inc.
Product Code	DXZ · Cardiovascular
Decision Date	Dec 27, 2000
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.3470
Device Class	Class 2

SURGISIS PERIPHERAL VASCULAR PATCH

Device Facts

Regulatory Classification

Identification