DNC 161 VINCA-FLO

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

510(k) Number

K770043 ↗

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

• DNC 162 Vinca-Flo

  Class II

  FDA 510(k) K770048 Active Cleared 14 Jan 1977

• 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

See all devices from Sorensen Research →

• What is the primary purpose of the DNC 161 VINCA-FLO in a hemodialysis procedure?

  The DNC 161 VINCA-FLO is designed as a hemodialysis blood circuit accessory to ensure the safe and efficient flow of blood through the dialysis machine. Its role is to facilitate proper filtration and exchange of fluids and waste products during the dialysis treatment, maintaining the integrity of the extracorporeal blood circuit.

• Is the DNC 161 VINCA-FLO intended for reuse, or is it meant for single-use only?

  The DNC 161 VINCA-FLO is explicitly supplied as a single-use component, meaning it is intended for one-time use in a clinical setting like a hospital or dialysis center. This design ensures patient safety and sterility, as reuse could introduce contamination risks.

• What regulatory pathway was followed for FDA clearance of this device, and when was it approved?

  The DNC 161 VINCA-FLO underwent a Traditional 510(k) review process, with a clearance decision dated January 14, 1977. It was determined to be substantially equivalent to a legally marketed predicate device, and the clearance was filed under product code KOC with the FDA.

• Are there multiple sizes or models of the DNC 161 VINCA-FLO, or is it available in a single configuration?

  The provided data lists multiple FEI numbers (e.g., 3033903155, 3027859369, etc.), which typically correspond to different lot or batch identifiers rather than distinct sizes or models. However, the core design remains consistent as a hemodialysis blood circuit accessory, so no variations in physical dimensions or configurations are explicitly documented in the available details.

• How should the DNC 161 VINCA-FLO be stored to maintain its integrity before use?

  While specific storage instructions aren’t detailed in the provided data, as a single-use medical device, it should be stored in a clean, dry environment protected from contamination, extreme temperatures, and direct sunlight. Follow manufacturer guidelines (available from Sorensen Research) for optimal shelf life and handling to ensure sterility and functionality before use.