510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K020728Substantially Equivalent

Miethke Shunt System

Aesculap Inc, Center Valley PA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K020728 is the FDA 510(k) clearance record for MIETHKE SHUNT SYSTEM, a class II device, cleared for Aesculap, Inc. on under FDA product code HCA (Catheter, Ventricular). FDA records list 269 510(k) clearances for Aesculap, Inc., from to . As of , FDA records show one recall naming K020728.

Clearance record

Decision date
Received
(30 days to decision)
Product code
HCA Catheter, Ventricular
Regulation
21 CFR 882.4100
Device class
Class II
Review panel
Neurology
Applicant
Aesculap, Inc. 3773 Corporate Pkwy., Center Valley PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HCA

Trailing 12 months

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

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