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510(k) K863982

VAS-CATH PERICARDIOCENTESIS CATHETER, SET & TRAY by Vas-Cath of Canada , Ltd. — Product Code JCY

K863982 is an FDA 510(k) premarket notification submitted by Vas-Cath of Canada , Ltd. for the device "VAS-CATH PERICARDIOCENTESIS CATHETER, SET & TRAY". The FDA issued a decision of Substantially Equivalent on October 24, 1986. The device falls under product code JCY (Catheter, Infusion), a Class I device regulated under 21 CFR 878.4200. Vas-Cath of Canada , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1986
Date Received
October 14, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Infusion
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

Other clearances by Vas-Cath of Canada , Ltd.

  • K875188 — LUER LOCK CONNECTORS / RIDIG P.V.C. (March 2, 1988)
  • K871817 — VAS-CATH PERITONEAL DIALYSIS CATHETER (July 16, 1987)
  • K871487 — VAS-CATH PERMANENT SINGLE LUMEN HEMODIALYSIS CATH (June 12, 1987)
  • K871488 — VAS-CATH PERMANENT DUAL LUMEN HEMODIALYSIS CATH (June 12, 1987)
  • K853283 — VACCESS TM 4006 (August 22, 1985)
  • K844854 — OPTI-FLOW DIGITAL SUBTRACTION ANGIOGRAPHY CAT-KIT (May 21, 1985)
  • K844800 — OPTI-FLOW & OPTI-TORQUE ANGIOGRAPHIC CATHETERS (May 16, 1985)
  • K850009 — EVANS, VAS-CATH EPIDURAL NEEDLE & CATHETER (May 13, 1985)
  • K844433 — VACCESS 2000 SINGLE LUMEN SUBCLAVIAN CANNULA (March 13, 1985)
  • K844434 — VACCESS 3000 SINGLE LUMEN JUGULAR CANNULA-CATH (March 13, 1985)

Other clearances for product code JCY

  • K840324 — SILICONE SUMP DRAIN 20 & 40 FRENCH (April 25, 1984)
  • K834615 — TRIPLE LUMEN INFUSIONCATHETERS- (February 14, 1984)
  • K831453 — SILCATH CENTRAL CATHETER TRAY W/18 GA (July 28, 1983)
  • K831451 — SILCATH CENTRAL CATHETER TRAY SIZE- (June 8, 1983)
  • K822096 — CHEMOTHERAPY INFUSION CATHETER (April 12, 1983)
  • K813606 — SILICONE ELASTOMER INFUSION CATHETER (January 18, 1982)
  • K791372 — JELCO & KVO CATHETER PLACEMENT UNIT (September 12, 1979)
  • K771861 — CATHETER, CEBTRAL VENOUS, 2N1501 (November 28, 1977)
  • K760760 — CATHETER, INTRAVASCULAR (ARGYLE IV SK) (December 9, 1976)
  • K760380 — INTRAVENOUS TRANSFER SET (INTRAFIX) (November 2, 1976)

FDA data resources