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510(k) K771429

DISP. TEFLON CONNHCTOR by Quinton, Inc. — Product Code FJQ

K771429 is an FDA 510(k) premarket notification submitted by Quinton, Inc. for the device "DISP. TEFLON CONNHCTOR". The FDA issued a decision of Substantially Equivalent on December 22, 1977. The device falls under product code FJQ (Connector, Shunt), a Class I 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
December 22, 1977
Date Received
August 1, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Connector, Shunt
Device Class
Class I
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 FJQ

  • K893679 — SHUNT CONNECTORS (July 24, 1989)
  • K771422 — PATIENT BY-PASS (January 3, 1978)

FDA data resources