510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K870186Substantially Equivalent

Endomyocardial Biopsy Device

Mansfield Scientific, Inc., Mansfield MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K870186 is the FDA 510(k) clearance record for ENDOMYOCARDIAL BIOPSY DEVICE, a class II device, cleared for Mansfield Scientific, Inc. on under FDA product code DWZ (Device, Biopsy, Endomyocardial). FDA records list 8 510(k) clearances for Mansfield Scientific, Inc., from to . As of , FDA records show no recalls naming K870186.

Clearance record

Decision date
Received
(35 days to decision)
Product code
DWZ Device, Biopsy, Endomyocardial
Regulation
21 CFR 870.4075
Device class
Class II
Review panel
Cardiovascular
Applicant
Mansfield Scientific, Inc. 135 Forbes Blvd., Mansfield MA
Third party review
No

Clearances, product code DWZ

Trailing 12 months

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

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