510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K771986Substantially Equivalent

Catheter, Mediastinal&pericardial

The Minnesota Back Brace Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K771986 is the FDA 510(k) clearance record for CATHETER, MEDIASTINAL&PERICARDIAL, a class II device, cleared for The Minnesota Back Brace Co. on under FDA product code FHF (System, Evacuator, Fluid). FDA records list one 510(k) clearance for The Minnesota Back Brace Co. As of , FDA records show no recalls naming K771986.

Clearance record

Decision date
Received
(9 days to decision)
Product code
FHF System, Evacuator, Fluid
Regulation
21 CFR 876.4370
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
The Minnesota Back Brace Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FHF

Trailing 12 months

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

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