510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K895511Substantially Equivalent

Catheter Balloon Dilator Pressure Gauge

Argon Medical Corp., Athens TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895511 is the FDA 510(k) clearance record for CATHETER BALLOON DILATOR PRESSURE GAUGE, a class II device, cleared for Argon Medical Corp. on under FDA product code MAV (Syringe, Balloon Inflation). FDA records list 28 510(k) clearances for Argon Medical Corp., from to . As of , FDA records show no recalls naming K895511.

Clearance record

Decision date
Received
(169 days to decision)
Product code
MAV Syringe, Balloon Inflation
Regulation
21 CFR 870.1650
Device class
Class II
Review panel
Cardiovascular
Applicant
Argon Medical Corp. 1445 Flat Creek Rd., Athens TX
Third party review
No

Clearances, product code MAV

Trailing 12 months
1 clearance under product code MAV in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MAV, 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 20261
October 20260