510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K900207Substantially Equivalent

Epicardia 4000

Medicomp, Inc., West Melbourne FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K900207 is the FDA 510(k) clearance record for EPICARDIA 4000, a class II device, cleared for Medicomp, Inc. on under FDA product code DST (Clip, Vena-Cava). FDA records list 23 510(k) clearances for Medicomp, Inc., from to . As of , FDA records show no recalls naming K900207.

Clearance record

Decision date
Received
(196 days to decision)
Product code
DST Clip, Vena-Cava
Regulation
21 CFR 870.3260
Device class
Class II
Review panel
Cardiovascular
Applicant
Medicomp, Inc. 7845 Ellis Rd., West Melbourne FL
Third party review
No

Clearances, product code DST

Trailing 12 months

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

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