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510(k) K821001

MCPARLAND SCALP VEIN CATHETER by Renal Systems, Inc. — Product Code LFJ

K821001 is an FDA 510(k) premarket notification submitted by Renal Systems, Inc. for the device "MCPARLAND SCALP VEIN CATHETER". The FDA issued a decision of Substantially Equivalent on July 22, 1982. The device falls under product code LFJ (Catheter, Subclavian), a Class II device regulated under 21 CFR 876.5540. Renal Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 1982
Date Received
April 8, 1982
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 Renal Systems, Inc.

  • K970648 — PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S) (January 5, 1998)
  • K861730 — ACTRIL FOR KIDNEY MACHINE DISINFECTANT (June 9, 1987)
  • K854011 — RENALFO HEMOFILTER CAVHD (November 5, 1985)
  • K844790 — RENAFLO HEMOCONCENTRATOR (May 23, 1985)
  • K843963 — DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD (January 7, 1985)
  • K844108 — RENAL SYSTEMS PERITONEAL ACCESS SYSTEM (January 7, 1985)
  • K842258 — RENATRON (July 6, 1984)
  • K841543 — CONCENTRATE CONDUCTIVITY METER (May 22, 1984)
  • K840182 — RENAPAK CONCENTRATE MIXING SYS. (May 2, 1984)
  • K840436 — HEMASITE/RENALOY -VASCULAR ACCESS SHUNT (February 21, 1984)

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