Home / 510(k) Clearances / K970287

510(k) K970287

LUMBAR PUNCTURE KIT by B.Braun Medical, Inc. — Product Code FMJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 1997
Date Received
January 24, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Manometer, Spinal-Fluid
Device Class
Class II
Regulation Number
880.2500
Review Panel
HO
Submission Type

Other clearances by B.Braun Medical, Inc.

  • K243392 — Infusomat® Space Volumetric Infusion Pump Administration Sets (July 24, 2025)
  • K240578 — VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter (July 31, 2024)
  • K241845 — Introcan Safety® 2 IV Catheter (July 26, 2024)
  • K241385 — Omnifix Syringe NRFit (July 13, 2024)
  • K231242 — Perifix FX Catheter; Contiplex FX Catheter (September 15, 2023)
  • K223479 — AQUAbase nX (August 16, 2023)
  • K220756 — Introcan Safety 2 IV Catheter (June 23, 2022)
  • K220626 — Introcan Safety IV Catheter (May 14, 2022)
  • K213778 — IV Administration Set (March 3, 2022)
  • K213664 — B. Braun Introcan Safety 2 IV Catheter (February 11, 2022)

Other clearances for product code FMJ

  • K170305 — Spinal Manometer NRFit; Spinal Manometer LUER (July 25, 2017)
  • K032432 — BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER (August 28, 2003)
  • K963570 — SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22) (October 18, 1996)
  • K910089 — MEGA LUMBAR PUNCTURE KIT (June 20, 1991)
  • K882405 — HYPODERMIC NEEDLE SHEATH HOLDER (June 29, 1988)