Burron Central Vein Catherization Kit

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

510(k) Number

K810461 ↗

FDA Product Code

DQY

Device Class

Class II

Regulation

21 CFR Part 870.1250

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Cavafix(R) Central Venous Catheter Kit W/Suture

  Class II

  FDA 510(k) K870403 Active Cleared 1 May 1987

• Perican, Epidural Cannula

  Class II

  FDA 510(k) K813179 Active Cleared 3 Dec 1981

• Bimeco Filtered Extension Set

  Class II

  FDA 510(k) K801605 Active Cleared 12 Aug 1980

• In-Stopper (Injection Cap

  Class II

  FDA 510(k) K813259 Active Cleared 31 Dec 1981

• Medifix

  Class II

  FDA 510(k) K813498 Active Cleared 7 Jan 1982

• Perfix Set for Epidural Anesthesia W/Tuo

  Class II

  FDA 510(k) K813186 Active Cleared 3 Dec 1981

See all devices from Burron Medical Products, Inc. →

• What is the Burron Central Vein Catheterization Kit used for?

  The Burron Central Vein Catheterization Kit is used for central venous access to support long-term intravenous therapy, hemodynamic monitoring, and rapid fluid resuscitation in clinical settings such as intensive care units, emergency departments, and operating rooms.

• How is the Burron Central Vein Catheterization Kit supplied and for what settings is it intended?

  The kit is supplied as a complete set for use in clinical environments including intensive care units, emergency departments, and operating rooms, where central venous access is required for therapy, monitoring, or resuscitation.

• What regulatory pathway was used for the Burron Central Vein Catheterization Kit and what is its authorization number?

  The Burron Central Vein Catheterization Kit was cleared via the traditional 510(k) pathway and is authorized under FDA 510(k) clearance K810461, with product code DQY, indicating it is substantially equivalent to a predicate device.