510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K992424Substantially Equivalent

Seldiflex Long-Term Central Venous Catheter(40cm & 60Cm in Length), Models 63244J20 & 63246J20

Plastimed Laboratoire Pharmaceutique, Cedex, FR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K992424 is the FDA 510(k) clearance record for SELDIFLEX LONG-TERM CENTRAL VENOUS CATHETER(40CM & 60CM IN LENGTH), MODELS 63244J20 & 63246J20, a class II device, cleared for Plastimed Laboratoire Pharmaceutique on under FDA product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days). FDA records list 2 510(k) clearances for Plastimed Laboratoire Pharmaceutique, from to . As of , FDA records show no recalls naming K992424.

Clearance record

Decision date
Received
(527 days to decision)
Product code
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Regulation
21 CFR 880.5970
Device class
Class II
Review panel
General Hospital
Applicant
Plastimed Laboratoire Pharmaceutique 95321 Saint-Lue-La-Foret, Cedex, FR
510(k) summary
Summary
Third party review
No

Clearances, product code LJS

Trailing 12 months
3 clearances under product code LJS in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LJS, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260