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510(k) K970997

NEO-CARE LUMBER PUNCTURE KIT by Klein-Baker Medical, Inc. — Product Code MIA

K970997 is an FDA 510(k) premarket notification submitted by Klein-Baker Medical, Inc. for the device "NEO-CARE LUMBER PUNCTURE KIT". The FDA issued a decision of Substantially Equivalent on May 22, 1997. The device falls under product code MIA (Needle, Spinal, Short Term), a Class II device regulated under 21 CFR 868.5150. Klein-Baker Medical, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 1997
Date Received
March 19, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Spinal, Short Term
Device Class
Class II
Regulation Number
868.5150
Review Panel
AN
Submission Type

Other clearances by Klein-Baker Medical, Inc.

  • K972731 — NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SET (September 29, 1997)
  • K970434 — NEO-PICC (April 1, 1997)
  • K963972 — NEO-CARE DUAL LUMEN UMBILICAL CATHETER (December 24, 1996)
  • K963867 — NEO-CARE CATHETERIZATION TRAY (November 6, 1996)

Other clearances for product code MIA

  • K172800 — Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point (June 14, 2018)
  • K051860 — FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837 (August 22, 2005)
  • K983858 — SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES (January 29, 1999)
  • K982269 — CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA AND (July 23, 1998)
  • K971645 — REGANES SPINAL NEEDLE (VARIOUS) (August 1, 1997)
  • K961324 — GLOBAL MEDICAL PRODUCTS SPINAL,CONICAL TIP (SPROTTLE STYLE), WHITACRE STYLE NEED (July 2, 1996)
  • K960405 — SPINAL NEEDLE (February 28, 1996)
  • K942442 — ACUFEX T-FIX DELIVERY SYSTEM (December 5, 1994)
  • K904380 — SPINAL CORD ACCESS EPIDURAL INTRODUCER SYSTEM (April 8, 1993)

FDA data resources