Home / 510(k) Clearances / K840415

510(k) K840415

HEMOCATH by Quinton, Inc. — Product Code FIQ

K840415 is an FDA 510(k) premarket notification submitted by Quinton, Inc. for the device "HEMOCATH". The FDA issued a decision of Substantially Equivalent on April 20, 1984. The device falls under product code FIQ (Cannula, A-V Shunt), a Class II device regulated under 21 CFR 876.5540. Quinton, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1984
Date Received
January 31, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, A-V Shunt
Device Class
Class II
Regulation Number
876.5540
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 FIQ

  • K892887 — ST SERIES SAF-T-SHUNTS ARTERIOVENOUS CANNULA (May 15, 1989)
  • K892666 — SAF-T-SHUNT, S-300 SERIES (May 4, 1989)
  • K892663 — S-100 ALLEN-BROWN SHUNT (May 4, 1989)
  • K844692 — PEDIATRIC SIZED HEMOCATH CATHETER (January 18, 1985)
  • K841791 — PLUME FISTULA NEEDLE (July 9, 1984)
  • K840322 — HEMOFILTRATION CATHETER HF-100 (April 24, 1984)
  • K834358 — PARALLEL DUAL LUMEN SUBCLAVIAN CANNULA (April 2, 1984)
  • K840436 — HEMASITE/RENALOY -VASCULAR ACCESS SHUNT (February 21, 1984)
  • K833622 — RENALLOY HEMASITE VASCULAR ACCESS SHUNT (November 29, 1983)
  • K831801 — HEMOCLAV VENOUS CATHETER (July 7, 1983)

FDA data resources