510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K852294Substantially Equivalent

Bard-Parker Occlusion Balloon Catheter

BD Becton Dickinson Vacutainer Systems Preanalytic, Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852294 is the FDA 510(k) clearance record for BARD-PARKER OCCLUSION BALLOON CATHETER, a class II device, cleared for Bd Becton Dickinson Vacutainer Systems Preanalytic on under FDA product code DYG (Catheter, Flow Directed). FDA records list 632 510(k) clearances for Bd Becton Dickinson Vacutainer Systems Preanalytic, from to . As of , FDA records show no recalls naming K852294.

Clearance record

Decision date
Received
(111 days to decision)
Product code
DYG Catheter, Flow Directed
Regulation
21 CFR 870.1240
Device class
Class II
Review panel
Cardiovascular
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic 1875 Eye St. NW Suite 625, Washington DC
Third party review
No

Clearances, product code DYG

Trailing 12 months

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

FDA records show no clearances under product code DYG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DYG, 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