510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K831931Substantially Equivalent

Atrium Thoracic Catheter

Atrium Medical Corporation, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831931 is the FDA 510(k) clearance record for ATRIUM THORACIC CATHETER, a class I device, cleared for Atrium Medical Corp. on under FDA product code GBZ (Catheter, Cholangiography). FDA records list 69 510(k) clearances for Atrium Medical Corp., from to . As of , FDA records show 13 recalls naming K831931.

Clearance record

Decision date
Received
(111 days to decision)
Product code
GBZ Catheter, Cholangiography
Regulation
21 CFR 878.4200
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Atrium Medical Corp. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code GBZ

Trailing 12 months

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

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