Question 1

Who is the manufacturer of VASCULAR PAWS?

Accepted Answer

Sil-Med Corp. filed the 510(k) submission for VASCULAR PAWS (K813062).

Question 2

What is the FDA product code for VASCULAR PAWS?

Accepted Answer

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

Question 3

When was VASCULAR PAWS cleared by the FDA?

Accepted Answer

Dec 14, 1981 (decision: SESE).

Question 4

What is the regulatory pathway for VASCULAR PAWS?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like VASCULAR PAWS?

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	K813062
Device Name	VASCULAR PAWS
Applicant	Sil-Med Corp.
Product Code	DXC · Cardiovascular
Decision Date	Dec 14, 1981
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.4450
Device Class	Class 2

VASCULAR PAWS

Device Facts

Regulatory Classification

Identification