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510(k) K943893

PERCUTANEOUS GRAINAGE CATHETER by Menlo Care, Inc. — Product Code LJE

K943893 is an FDA 510(k) premarket notification submitted by Menlo Care, Inc. for the device "PERCUTANEOUS GRAINAGE CATHETER". The FDA issued a decision of Substantially Equivalent on March 7, 1995. The device falls under product code LJE (Catheter, Nephrostomy), a Class U device. Menlo Care, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 1995
Date Received
August 9, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Nephrostomy
Device Class
Class U
Regulation Number
Review Panel
GU
Submission Type

Other clearances by Menlo Care, Inc.

  • K964447 — PICC CATHETER/MIDLINE CATHETER (April 16, 1997)
  • K951620 — MIDMARK MIDLINE CATHETER (April 4, 1996)
  • K945521 — CENTERMARK(R) PICC INSERTION TRAY LANDMARK(R) MIDLINE CATHETER PREP TRAY (April 6, 1995)
  • K950737 — LANDMARK MIDLINE CATHETER (March 29, 1995)
  • K944968 — LANDMARK MIDLINE CATHETER (March 29, 1995)
  • K943143 — BILIARY STENT (February 28, 1995)
  • K930048 — SAFE-PICC CATHETER (May 12, 1994)
  • K933941 — MENLO CARE URINARY DIVERSION STENT (March 31, 1994)
  • K940127 — CENTERMARK SECURING WINGS (February 9, 1994)
  • K923394 — MENLO CARE AQUASTENT SET (November 16, 1993)

Other clearances for product code LJE

  • K250448 — Disposable Percutaneous Nephrostomy Dilatation Kit (July 3, 2025)
  • K222705 — Introducer Needle (May 22, 2023)
  • K211911 — Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kit (March 10, 2022)
  • K201165 — In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath (December 17, 2020)
  • K191498 — Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrath (January 29, 2020)
  • K190903 — Lawson Retrograde Nephrostomy Wire Puncture Set (December 16, 2019)
  • K183051 — Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set (July 16, 2019)
  • K183035 — Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Tro (May 17, 2019)
  • K181735 — Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set (March 27, 2019)
  • K181713 — Ultraxx Nephrostomy Balloon Catheter Set (August 17, 2018)

FDA data resources