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510(k) K871730

MODIFIED USE OF PULL-APART INTRODUCER SET by Quinton, Inc. — Product Code FKO

K871730 is an FDA 510(k) premarket notification submitted by Quinton, Inc. for the device "MODIFIED USE OF PULL-APART INTRODUCER SET". The FDA issued a decision of Substantially Equivalent on May 18, 1987. The device falls under product code FKO (Catheter, Peritoneal Dialysis, Single Use), a Class II device regulated under 21 CFR 876.5630. Quinton, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 1987
Date Received
May 5, 1987
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 Quinton, Inc.

  • K032038 — PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601 (September 5, 2003)
  • K021906 — QUINTON Q-CATH, MODEL 000460 (September 4, 2002)
  • K003576 — Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503 (January 25, 2001)
  • K001492 — QUINTON Q-STRESS, MODEL 000483 (August 9, 2000)
  • K992908 — Q-TEL TELEMETRY SYSTEM V. 6.0 (ST) (March 6, 2000)
  • K990866 — QUINTON MEDTRACK CR PLUS TREADMILL (April 29, 1999)
  • K971397 — VIEWCATH 3-D CATHETER PULLBACK (August 25, 1997)
  • K964784 — SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431) (August 13, 1997)
  • K964978 — VITAL STATISTICS SYSTEM (O-CATH ACCESSORY) (May 21, 1997)
  • K955002 — MAHURKAR 8 FR DUAL LEMEN CATHETER (September 13, 1996)

Other clearances for product code FKO

  • K964514 — CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSIS (June 26, 1998)
  • 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)
  • 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