510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K852642Substantially Equivalent

Central Vein Catheterization Tray

Teleflexmedical, Inc., Jeffrey NH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852642 is the FDA 510(k) clearance record for CENTRAL VEIN CATHETERIZATION TRAY, a class I device, cleared for Teleflexmedical, Inc. on under FDA product code FDZ (Attachment, Eyepiece, For Insertion Of Prescription Lens). FDA records list 64 510(k) clearances for Teleflexmedical, Inc., from to . As of , FDA records show no recalls naming K852642.

Clearance record

Decision date
Received
(209 days to decision)
Product code
FDZ Attachment, Eyepiece, For Insertion Of Prescription Lens
Regulation
21 CFR 876.1500
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Teleflexmedical, Inc. Tall Pines Park, Jeffrey NH
Third party review
No

Clearances, product code FDZ

Trailing 12 months

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

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