510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K062302Substantially Equivalent

Millicore Ab Digivent Chest Drainage System

Millicore AB, North Attleboro MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K062302 is the FDA 510(k) clearance record for MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM, a class II device, cleared for Millicore AB on under FDA product code KDQ (Bottle, Collection, Vacuum). FDA records list one 510(k) clearance for Millicore AB. As of , FDA records show no recalls naming K062302.

Clearance record

Decision date
Received
(59 days to decision)
Product code
KDQ Bottle, Collection, Vacuum
Regulation
21 CFR 880.6740
Device class
Class II
Review panel
General Hospital
Applicant
Millicore AB 49 Plain St., North Attleboro MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KDQ

Trailing 12 months

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

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