Medical Device Manufacturer · US , Walker , MI

Luther Medical Products, Inc. - FDA 510(k) Cleared Devices

17 submissions · 16 cleared · Since 1980

Recent clearances: BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB, ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60CM), L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24 GA. KIT, L-CATH MODIFIED SELDINGER

17

Total

16

Cleared

0

Denied

FDA 510(k) Regulatory Record - Luther Medical Products, Inc. Cardiovascular ✕

4 devices

1-4 of 4

Cleared Nov 30, 1998

BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB

Cardiovascular · 112d

Cleared May 27, 1993

DUAL LUMEN L-CATH CATHETER SYSTEM

Cardiovascular · 183d

Cleared Feb 25, 1993

CATHETER INTRODUCER

Cardiovascular · 169d

Cleared Jan 29, 1982

SUBCLAVIAN JUGULAR CATHETER SET

Cardiovascular · 14d