MCSCK638 CATHETER IN A TRAY (KIT)— 510(k) K821955

Substantially Equivalent

Medcomp

FDA 510(k) clearance K821955 for MCSCK638 CATHETER IN A TRAY (KIT), Substantially Equivalent on 1982-07-14. Applicant: Medcomp. Device class: 2.

Clearance details

Applicant: Medcomp
Product code: Code LFJ
Device class: Class 2
Regulation: 21 CFR 876.5540
Advisory panel: Gastroenterology, Urology
Date received: 1982-06-30
Decision date: 1982-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LFJ

K920780 — MEDSURG INSERTION TRAY1994-08-19
K925819 — AKCESS0CATH KIT1994-08-02
K925818 — AKCESS-CATH1994-04-05
K913468 — ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAY1994-03-24
K920634 — SPLITTABLE SHEATH INTRODUCER SET1994-01-14

More clearances from Medcomp

K130889 — SPLIT CATH RG2014-04-28
K123292 — T32013-06-11
K102966 — 2.6F X 20CM VASCU-PICC, 2.6F X 50CM VASCU-PICC2010-12-21
K091954 — MICRO-STICK SET2010-01-08
K091953 — PRO-PICC2009-09-16

Data sourced from openFDA. This site is unofficial and independent of the FDA.