B-D Ultra-Vue Procedure Needle W/ Chiba Type Point

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K915481 ↗

FDA Product Code

DWD

Device Class

Class II

Regulation

21 CFR Part 870.4430

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Leuco Prep

  Class I

  FDA 510(k) K854093 Active Cleared 12 Nov 1985

• Qbc System Hemoglobin

  Class II

  FDA 510(k) K874427 Active Cleared 5 Jan 1988

• Sensicare Synthetic Medical Gloves

  Class I

  FDA 510(k) K915478 Active Cleared 27 Jan 1992

• Qbc Centrifugal Hematology Analyzer

  Class II

  FDA 510(k) K844645 Active Cleared 5 Mar 1985

• Holesterol Delta Test Assay

  Class I

  FDA 510(k) K771582 Active Cleared 13 Sep 1977

• Delta Test Triglycerides

  Class I

  FDA 510(k) K802136 Active Cleared 10 Oct 1980

See all devices from Bd Becton Dickinson Vacutainer Systems Preanalytic →

• What is the B-D Ultra-Vue Procedure Needle with Chiba Type Point used for?

  This needle is designed specifically for cardiopulmonary bypass procedures, where controlled aspiration and fluid management are critical. Its Chiba-type point ensures precise, low-trauma insertion into delicate cardiac tissues, reducing damage during intracardiac access and suction control. It is ideal for operating rooms or cardiac catheterization labs where cardiovascular interventions require minimal tissue disruption.

• Is the B-D Ultra-Vue Procedure Needle single-use or reusable?

  The B-D Ultra-Vue Procedure Needle is intended for single-use only. This design ensures sterility and safety, as reuse could compromise integrity and introduce infection risks. The device is supplied sterile and must not be reprocessed or reused after a single procedure.

• What regulatory approval does this needle hold, and where is it classified?

  The needle holds FDA 510(k) clearance (K915481) under the Traditional clearance type, classified as a Class II medical device (Regulation Number 870.4430). It was reviewed by the Cardiovascular (CV) Advisory Committee and is substantiated as substantially equivalent to its predicate device. This classification reflects its role in controlled clinical settings like operating rooms or catheterization labs.

• How should the B-D Ultra-Vue Procedure Needle be stored before use?

  The needle must be stored in its original, unopened packaging to maintain sterility. Keep it in a clean, dry environment away from direct sunlight, extreme temperatures, or contaminants. Avoid exposure to moisture or chemical fumes, as these could compromise the device’s integrity. Always adhere to manufacturer guidelines for storage to ensure readiness for sterile use.

• Are there specific sizes or models available for this needle?

  The provided data does not specify individual sizes or model variants beyond the Chiba-type point design for intracardiac use. However, the needle is tailored for cardiovascular procedures requiring precise suction control. For exact sizing or model-specific details, refer to the product labeling or consult the manufacturer’s technical documentation, as variations may exist for different procedural needs.