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510(k) K895506

FLEXXICON PLUS DUAL LUMEN DIALYSIS CATHETER by Vas-Cath, Inc. — Product Code LFJ

K895506 is an FDA 510(k) premarket notification submitted by Vas-Cath, Inc. for the device "FLEXXICON PLUS DUAL LUMEN DIALYSIS CATHETER". The FDA issued a decision of Substantially Equivalent on February 9, 1990. The device falls under product code LFJ (Catheter, Subclavian), a Class II device regulated under 21 CFR 876.5540. Vas-Cath, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 1990
Date Received
September 12, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Subclavian
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)
  • K965178 — NIAGARA DUAL LUMEN CATHETER (August 19, 1997)
  • 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)
  • K914162 — VAS-CATH FLEXXICON 2 DUAL LUMEN DIALYSIS CATHETERS (July 1, 1993)
  • K914210 — VAS-CATH DUALATOR(TM) VESSEL DILATOR (July 1, 1993)
  • K914976 — OPTI-PLAST 5F PTA CATHETERS, MODIFICATION (January 27, 1992)

Other clearances for product code LFJ

  • K920780 — MEDSURG INSERTION TRAY (August 19, 1994)
  • K925819 — AKCESS0CATH KIT (August 2, 1994)
  • K925818 — AKCESS-CATH (April 5, 1994)
  • K913468 — ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAY (March 24, 1994)
  • K931120 — COAXIAL ACUTE CATHETER (January 14, 1994)
  • K920634 — SPLITTABLE SHEATH INTRODUCER SET (January 14, 1994)
  • K914162 — VAS-CATH FLEXXICON 2 DUAL LUMEN DIALYSIS CATHETERS (July 1, 1993)
  • K915423 — HEMO-CATH SILICONE ACCESS CATHETER (February 2, 1993)
  • K914826 — AKCESS-CATH KIT (April 10, 1992)
  • K910501 — PERMANENT SILICONE CATHETERS (April 29, 1991)

FDA data resources