510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K812761Substantially Equivalent

Flow-Directed Balloon Thermodilution

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

K812761 is the FDA 510(k) clearance record for FLOW-DIRECTED BALLOON THERMODILUTION, a class III device, cleared for Nova Medical Specialties on under FDA product code KRG (Programmer, Pacemaker). FDA records list 11 510(k) clearances for Nova Medical Specialties, from to . As of , FDA records show no recalls naming K812761.

Clearance record

Decision date
Received
(32 days to decision)
Product code
KRG Programmer, Pacemaker
Regulation
21 CFR 870.3700
Device class
Class III
Review panel
Cardiovascular
Applicant
Nova Medical Specialties 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KRG

Trailing 12 months

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

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