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510(k) K954147

MANAN MALECOT BASKET DRAINAGE CATHETER by Manan Medical Products, Inc. — Product Code FEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 1996
Date Received
September 5, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Malecot
Device Class
Class II
Regulation Number
876.5090
Review Panel
GU
Submission Type

Other clearances by Manan Medical Products, Inc.

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  • K011209 — MANAN SPRITACRE SPINAL NEEDLES (June 26, 2001)
  • 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)

Other clearances for product code FEW

  • K140085 — UNIVERSA PERCULTANEOUS DRAINAGE CATHETER (November 18, 2014)
  • K070879 — BARD MALECOT AND PEZZER DRAINS (April 24, 2007)
  • K981258 — MANAN MALECOT BASKET DRAINAGE CATHETER (April 22, 1998)
  • K954116 — SILICONE MALECOT CATHETER WITH PEZZER/MUSHROOM TIP (November 6, 1995)
  • K920423 — OLYMPIC SMART SCALE CARE CENTER (June 11, 1992)