DNC 162 Vinca-Flo

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

510(k) Number

K770048 ↗

FDA Product Code

KOC

Device Class

Class II

Regulation

21 CFR Part 876.5820

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Introducer, Cat. #int-05FR.

  Class II

  FDA 510(k) K771042 Active Cleared 13 Jul 1977

• Transducer Dome DS106

  Class II

  FDA 510(k) K833096 Active Cleared 3 Nov 1983

• Intk-08 8 French Introducer Kit W/Side

  Class II

  FDA 510(k) K812325 Active Cleared 21 Sep 1981

• Introducer, Cat. #int-06FR.

  Class II

  FDA 510(k) K771041 Active Cleared 13 Jul 1977

• Tall Floor Stand Tfs-01

  Class II

  FDA 510(k) K831939 Active Cleared 19 Jul 1983

• Disposable Transducer

  Class II

  FDA 510(k) K813464 Active Cleared 7 Jan 1982

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• What is the DNC 162 VINCA-FLO catheter used for?

  The DNC 162 VINCA-FLO is a femoral catheter specifically designed for use in hemodialysis blood circuits. It facilitates the flow of blood between the patient and the dialysis machine, enabling efficient filtration during dialysis procedures while minimizing trauma to the vessel. This makes it ideal for maintaining stable vascular access in hemodialysis centers.

• Is the DNC 162 VINCA-FLO catheter single-use or reusable?

  The DNC 162 VINCA-FLO catheter is supplied as a single-use device. This design ensures sterility and reduces the risk of contamination or cross-infection between patients, adhering to standard sterile medical device protocols for clinical settings like hemodialysis centers.

• How should the DNC 162 VINCA-FLO catheter be stored?

  The DNC 162 VINCA-FLO catheter must be stored according to standard sterile medical device protocols. This includes maintaining its sterile packaging until immediate use and ensuring it is kept in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its integrity and sterility.

• What regulatory pathway does the DNC 162 VINCA-FLO catheter follow?

  The DNC 162 VINCA-FLO catheter is classified as a Class II medical device under FDA regulation 876.5820 and has received FDA clearance (K770048) through the 510(k) pathway. The decision was granted as Substantially Equivalent (SESE) in 1977, confirming its compliance with applicable standards for hemodialysis accessories.

• Is the DNC 162 VINCA-FLO catheter compatible with MRI?

  There is no noted MRI compatibility for the DNC 162 VINCA-FLO catheter in the available documentation. Clinicians should verify compatibility with their specific MRI equipment and protocols before use, as metal components or other materials in catheters may pose risks in magnetic fields.