510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K992441Substantially Equivalent

Advanta Graft

Atrium Medical Corporation, Hudson NH / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K992441 is the FDA 510(k) clearance record for ADVANTA GRAFT, a class II device, cleared for Atrium Medical Corp. on under FDA product code DYF (Prosthesis, Vascular Graft, Of Less Then 6mm Diameter). FDA records list 69 510(k) clearances for Atrium Medical Corp., from to . As of , FDA records show one recall naming K992441.

Clearance record

Decision date
Received
(29 days to decision)
Product code
DYF Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
Regulation
21 CFR 870.3450
Device class
Class II
Review panel
Cardiovascular
Applicant
Atrium Medical Corp. 5 Wentworth Dr., Hudson NH
510(k) summary
Statement
Third party review
No

Clearances, product code DYF

Trailing 12 months

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

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