510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163524Substantially Equivalent

Vessel Dilator

Fetzer Medical GmbH & Co.KG, Tuttlingen, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163524 is the FDA 510(k) clearance record for Vessel Dilator, a class II device, cleared for Fetzer Medical GmbH & Co. KG on under FDA product code DWP (Dilator, Vessel, Surgical). FDA records list 3 510(k) clearances for FETZER MEDICAL GMBH & CO.KG, from to . As of , FDA records show no recalls naming K163524.

Clearance record

Decision date
Received
(196 days to decision)
Product code
DWP Dilator, Vessel, Surgical
Regulation
21 CFR 870.4475
Device class
Class II
Review panel
Cardiovascular
Applicant
Fetzer Medical GmbH & Co. KG Unter Buchsteig 5, Tuttlingen, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DWP

Trailing 12 months

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

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