510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K082725Substantially Equivalent

Graftguard Pressure Controlling Syringe

Maquet Cardiovascular LLC, San Jose CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K082725 is the FDA 510(k) clearance record for GRAFTGUARD PRESSURE CONTROLLING SYRINGE, a class I device, cleared for Maquet Cardiovascular, LLC on under FDA product code GBX (Catheter, Irrigation). FDA records list 14 510(k) clearances for Maquet Cardiovascular, LLC, from to . As of , FDA records show one recall naming K082725.

Clearance record

Decision date
Received
(91 days to decision)
Product code
GBX Catheter, Irrigation
Regulation
21 CFR 878.4200
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Maquet Cardiovascular, LLC 170 Baytech Dr., San Jose CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GBX

Trailing 12 months

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

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