510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K792646Substantially Equivalent

Amp Direct Vascular Monitoring System

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

K792646 is the FDA 510(k) clearance record for AMP DIRECT VASCULAR MONITORING SYSTEM, a class II device, cleared for American Medical Products, Inc. on under FDA product code KRH (Ring, Annuloplasty). FDA records list 30 510(k) clearances for American Medical Products, Inc., from to . As of , FDA records show no recalls naming K792646.

Clearance record

Decision date
Received
(52 days to decision)
Product code
KRH Ring, Annuloplasty
Regulation
21 CFR 870.3800
Device class
Class II
Review panel
Cardiovascular
Applicant
American Medical Products, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KRH

Trailing 12 months
2 clearances under product code KRH in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KRH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260