510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853362Substantially Equivalent

H-H Slotted Ventricular Catheter/slotted Catheter

Holter-Hausner Intl., Bridgeport PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853362 is the FDA 510(k) clearance record for H-H SLOTTED VENTRICULAR CATHETER/SLOTTED CATHETER, a class II device, cleared for Holter-Hausner Intl. on under FDA product code JXG (Shunt, Central Nervous System And Components). FDA records list 42 510(k) clearances for Holter-Hausner Intl., from to . As of , FDA records show 3 recalls naming K853362.

Clearance record

Decision date
Received
(22 days to decision)
Product code
JXG Shunt, Central Nervous System And Components
Regulation
21 CFR 882.5550
Device class
Class II
Review panel
Neurology
Applicant
Holter-Hausner Intl. Third And Mill St.S, Bridgeport PA
Third party review
No

Clearances, product code JXG

Trailing 12 months
4 clearances under product code JXG in the twelve months to October 2026, November 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code JXG, trailing twelve months
MonthClearances
November 20252
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260