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510(k) K953713

MANAN GENERAL UTILITY DRAINAGE CATHETER by Manan Medical Products, Inc. — Product Code LJE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 1996
Date Received
July 19, 1995
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

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  • K983620 — MANAN SPINAL NEEDLES (January 8, 1999)
  • K980536 — EPIDURAL NEEDLE (July 31, 1998)
  • K981386 — MANAN BLUNT NEEDLE (June 29, 1998)
  • K980211 — MRI CHIBA,SPINAL,BREAST LOCALIZATION,AUTOMATIC CUTTING NEEDLES (February 6, 1998)
  • K974446 — MANAN AUTOMATIC CUTTING NEEDLE (January 8, 1998)
  • K962977 — MRI COMPATIBLE BIOPSY NEEDLES (October 9, 1997)
  • K963767 — MANAN V.S. ACCESS NEEDLE/SET (May 16, 1997)
  • K961986 — MANAN D BAG (March 13, 1997)

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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)