510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K980090Substantially Equivalent

Onecath, L-Cath Catheter System, Model Oc-(16-22 Ga., 5Cm-60Cm)

Luther Medical Products, Inc., Newport Beach CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980090 is the FDA 510(k) clearance record for ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60CM), a class II device, cleared for Luther Medical Products, Inc. on under FDA product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days). FDA records list 17 510(k) clearances for Luther Medical Products, Inc., from to . As of , FDA records show no recalls naming K980090.

Clearance record

Decision date
Received
(74 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
Luther Medical Products, Inc. 530 Kings Rd., Newport Beach CA
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