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510(k) K964514

CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSIS by Corpak, Inc. — Product Code FKO

K964514 is an FDA 510(k) premarket notification submitted by Corpak, Inc. for the device "CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSIS". The FDA issued a decision of Substantially Equivalent on June 26, 1998. The device falls under product code FKO (Catheter, Peritoneal Dialysis, Single Use), a Class II device regulated under 21 CFR 876.5630. Corpak, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 1998
Date Received
October 29, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Peritoneal Dialysis, Single Use
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type

Other clearances by Corpak, Inc.

  • K970178 — CLOG ZAPPER ENTERAL FEEDING TUBE DECLOGGING SYSTEM (July 21, 1997)
  • K935512 — CORPAK REPLACEMENT GASTROSTOMY DEVICE STOMACORE (August 29, 1996)
  • K944750 — CORFLO 300 PUMP (June 19, 1995)
  • K931921 — CORPAK GASTROSTOMY TUBE (June 9, 1995)
  • K932847 — CORPAK ENTERAL PUMP (June 17, 1994)
  • K902949 — CORPAK GRASPING FORCEPS (August 30, 1990)
  • K901501 — CORPAK GASTROSTOMY TUBE (June 11, 1990)
  • K882867 — CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE (September 21, 1988)
  • K853253 — CORPAK FARRELL VALVE ENTERAL GASTRIC PRESSURE RELI (November 5, 1985)
  • K852792 — CORPAK ENTERAL SOL ADM PUMP SET W/ SCREW (August 8, 1985)

Other clearances for product code FKO

  • K974570 — PERITONEAL DIALYSIS CATHETER CONNECTOR (February 27, 1998)
  • K910787 — TITANIUM CONNECTOR (2 PART) (August 15, 1991)
  • K885037 — AMUKIN 50% - AIRSPRAY(R) (October 19, 1990)
  • K874650 — PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM) (December 9, 1987)
  • K872221 — DIALY-NATE SET & DIALY-NATE CATHETER (October 13, 1987)
  • K871730 — MODIFIED USE OF PULL-APART INTRODUCER SET (May 18, 1987)
  • K870472 — ACUTE PERITONEAL DIALYSIS KIT (February 25, 1987)
  • K860155 — PERITONEAL LAVAGE CATH PLC-8,SET PLS-8, KIT PLK-8 (February 14, 1986)
  • K854966 — ACUTE PERITONEAL DIALYSIS CATHETERS (January 9, 1986)
  • K845041 — CAPD STAGED CONNECTOR (February 21, 1985)

FDA data resources