510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K112683Substantially Equivalent

Smi Cardiovascular Pach

Solimas Medical, Inc., Sunny Vale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K112683 is the FDA 510(k) clearance record for SMI CARDIOVASCULAR PACH, a class II device, cleared for Solimas Medical, Inc. on under FDA product code DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene). FDA records list one 510(k) clearance for Solimas Medical, Inc. As of , FDA records show no recalls naming K112683.

Clearance record

Decision date
Received
(90 days to decision)
Product code
DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Regulation
21 CFR 870.3470
Device class
Class II
Review panel
Cardiovascular
Applicant
Solimas Medical, Inc. 443 Costa Mesa Ter., Sunny Vale CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DXZ

Trailing 12 months

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

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