510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K820887Substantially Equivalent

Mitral Valve Orifice Sizer

Celtech, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K820887 is the FDA 510(k) clearance record for MITRAL VALVE ORIFICE SIZER, a class I device, cleared for Celtech on under FDA product code DTI (Sizer, Heart-Valve, Prosthesis). FDA records list one 510(k) clearance for Celtech. As of , FDA records show no recalls naming K820887.

Clearance record

Decision date
Received
(100 days to decision)
Product code
DTI Sizer, Heart-Valve, Prosthesis
Regulation
21 CFR 870.3945
Device class
Class I
Review panel
Cardiovascular
Applicant
Celtech 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DTI

Trailing 12 months

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

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