Vascular Paws

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K813062 ↗

FDA Product Code

DXC

Device Class

Class II

Regulation

21 CFR Part 870.4450

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Sil-Med Waste Fluid Dump Bag

  Class I

  FDA 510(k) K891471 Active Cleared 15 Aug 1989

• Silmed Nasal Septal Button

  Unclassified

  FDA 510(k) K013696 Active Cleared 28 Nov 2001

• Antimicrobial Peritoneal Dialysis Coil Catheter with Spi-Argent II

  Class II

  FDA 510(k) K961392 Active Cleared 18 Jul 1997

• Penrose Drain Models 6001 - 6007

  Class I

  FDA 510(k) K960099 Active Cleared 11 Mar 1996

• Sil-Med Flat Suction Drain

  Class I

  FDA 510(k) K921424 Active Cleared 28 Sep 1992

• Antimicrobial Mediastinal Silicone Drain

  Class I

  FDA 510(k) K961194 Active Cleared 8 Aug 1996

See all devices from Sil-Med Corp. →

• What is the Vascular Paws used for?

  The Vascular Paws is designed to secure vascular lines, catheters, or other tubular devices to the skin during vascular procedures. Its purpose is to provide stability and minimize the risk of accidental dislodgement or infection, which is particularly important in high-risk environments such as intensive care units, hemodialysis sessions, or perioperative care.

• Is the Vascular Paws sterile and single-use?

  Yes, the Vascular Paws is supplied as a sterile, single-use device. This ensures patient safety by preventing cross-contamination and maintaining aseptic conditions during use, as required for vascular access procedures.

• How is the Vascular Paws applied to the skin?

  The device is intended for direct application to the skin following standard aseptic techniques. This means proper cleaning and preparation of the skin site are essential before securing the Vascular Paws to ensure optimal adhesion and infection control.

• What regulatory clearance does the Vascular Paws hold?

  The Vascular Paws holds FDA 510(k) clearance under the reference number K813062. It was determined to be substantially equivalent to a predicate device by the Cardiovascular (CV) Advisory Committee, confirming its compliance with FDA standards for vascular access devices.

• Can the Vascular Paws be reused?

  No, the Vascular Paws is explicitly designed for single-use only. Reusing medical devices like this can compromise sterility, increase infection risks, and violate regulatory guidelines, so it should never be reused after a single application.