510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K242429Substantially Equivalent

CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System

Becton Dickinson Inc. (BD), Salt Lake Ciy, UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K242429 is the FDA 510(k) clearance record for CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System, a class II device, cleared for Becton Dickinson Inc. (Bd) on under FDA product code SEF (Central Venous Catheter With Manual Insertion System). FDA's definition for product code SEF reads: "A central venous catheter with manual insertion system is intended to provide short-term access (<30 days) to the central venous system. The manual insertion system is attached to the catheter and facilitates placement in the targeted...". FDA records list one 510(k) clearance for Becton Dickinson Inc. (Bd). As of , FDA records show no recalls naming K242429.

Clearance record

Decision date
Received
(237 days to decision)
Product code
SEF Central Venous Catheter With Manual Insertion System
Regulation
21 CFR 880.5200
Device class
Class II
Review panel
General Hospital
Applicant
Becton Dickinson Inc. (Bd) 605 N. 5600 W., Salt Lake Ciy, UT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SEF

Trailing 12 months

FDA records hold no clearances under product code SEF in the trailing twelve months.

FDA records show no clearances under product code SEF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code SEF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260