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510(k) K965178

NIAGARA DUAL LUMEN CATHETER by Vas-Cath, Inc. — Product Code MPB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 1997
Date Received
December 24, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Hemodialysis, Non-Implanted
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
Submission Type

Other clearances by Vas-Cath, Inc.

  • K973013 — OPTI-PLAST (CENTURION) 5.5F ANGIOPLASTY CATHETER (June 19, 1998)
  • K964881 — ULTRAVERSE PTA CATHETER (May 28, 1997)
  • K970725 — OPTI-PLAST XL 5.5 F PTA CATHETER (May 9, 1997)
  • K941706 — OPTI-PLAST ANGIOPLASTY CATHETER (October 18, 1994)
  • K925485 — VAS-CATH INC. OPTI-PLAST ANGIOPLASTY CATHETER (March 10, 1994)
  • K933483 — OPTI-PLAST 5F PTA CATHETERS (September 24, 1993)
  • K914210 — VAS-CATH DUALATOR(TM) VESSEL DILATOR (July 1, 1993)
  • K914162 — VAS-CATH FLEXXICON 2 DUAL LUMEN DIALYSIS CATHETERS (July 1, 1993)
  • K914976 — OPTI-PLAST 5F PTA CATHETERS, MODIFICATION (January 27, 1992)
  • K914500 — OPTI-PLAST 5F PTA CATHETERS, MODIFICATION (December 31, 1991)

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  • K122091 — COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO H (July 29, 2013)
  • K120674 — MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER (April 4, 2012)
  • K110793 — AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KI (December 16, 2011)