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510(k) K943893

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

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)

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  • 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)
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  • 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)