Home / 510(k) Clearances / K981258

510(k) K981258

MANAN MALECOT BASKET DRAINAGE CATHETER by Medical Device Technologies, Inc. — Product Code FEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 1998
Date Received
April 6, 1998
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 Medical Device Technologies, Inc.

  • K101832 — BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT (August 27, 2010)
  • K053518 — INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR (January 26, 2006)
  • K051421 — INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR (August 30, 2005)
  • K050873 — CANALIZER HYDROPHILIC GUIDE WIRE (May 26, 2005)
  • K043523 — INTERV BRAND SNARELOK BONE MARROW BIOPSY NEEDLE (February 11, 2005)
  • K042464 — V-CORE FULL CORE BREAST BIOPSY INSTRUMENT (September 30, 2004)
  • K040427 — FIBREX CATHETER PATENCY DEVICE (May 3, 2004)
  • K031442 — PBN GUIDEWIRES (August 13, 2003)
  • K021606 — EN-SNARE ENDOVASCULAR SNARE AND CATHETER (May 31, 2002)
  • K011790 — MICROCRUISER PLUS INTRODUCER SET (September 5, 2001)

Other clearances for product code FEW

  • K140085 — UNIVERSA PERCULTANEOUS DRAINAGE CATHETER (November 18, 2014)
  • K070879 — BARD MALECOT AND PEZZER DRAINS (April 24, 2007)
  • K954147 — MANAN MALECOT BASKET DRAINAGE CATHETER (March 26, 1996)
  • K954116 — SILICONE MALECOT CATHETER WITH PEZZER/MUSHROOM TIP (November 6, 1995)
  • K920423 — OLYMPIC SMART SCALE CARE CENTER (June 11, 1992)