510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K830189Substantially Equivalent

Cardiovascular Saw Blades

Temp Medical Products, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K830189 is the FDA 510(k) clearance record for CARDIOVASCULAR SAW BLADES, a class I device, cleared for Temp Medical Products, Inc. on under FDA product code DWH (Blade, Saw, Surgical, Cardiovascular). FDA records list 2 510(k) clearances for Temp Medical Products, Inc., from to . As of , FDA records show no recalls naming K830189.

Clearance record

Decision date
Received
(64 days to decision)
Product code
DWH Blade, Saw, Surgical, Cardiovascular
Regulation
21 CFR 878.4820
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Temp Medical Products, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DWH

Trailing 12 months

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

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