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510(k) K974570

PERITONEAL DIALYSIS CATHETER CONNECTOR by Medigroup, Inc. — Product Code FKO

K974570 is an FDA 510(k) premarket notification submitted by Medigroup, Inc. for the device "PERITONEAL DIALYSIS CATHETER CONNECTOR". The FDA issued a decision of Substantially Equivalent on February 27, 1998. The device falls under product code FKO (Catheter, Peritoneal Dialysis, Single Use), a Class II device regulated under 21 CFR 876.5630. Medigroup, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1998
Date Received
December 8, 1997
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 Medigroup, Inc.

  • K120130 — FALLER TROCAR (May 21, 2012)
  • K071167 — FLEX-NECK EXXTENDED PERITONEAL DIALYSIS CATHETER AND ACCESSORIES, MODEL CF-5560 (August 31, 2007)
  • K070730 — FLEX-NECK ARC CATHETER (July 3, 2007)
  • K060897 — EMBEDDING TOOL, MODEL TE-1000 (July 18, 2006)
  • K031351 — FLEX-NECK PD CATHETER, INFANT (September 17, 2003)
  • K823294 — MEDIGROUP LS-110 LIGHT SOURCE (May 9, 1983)
  • K823295 — MEDIGROUP 2.2MM NEEDLESCOPE CANNULA& (May 6, 1983)
  • K823297 — ST-610 NEEDLESCOPE STERILIZATION TRAY (May 6, 1983)
  • K823293 — MEDIGROUP LG-102 LIGHT GUIDE (May 5, 1983)
  • K823296 — PC-205 TENCKHOFF CATHETER ROD OBTURATOR (January 26, 1983)

Other clearances for product code FKO

  • K964514 — CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSIS (June 26, 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