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510(k) K992907

INTRADUCER by Taut, Inc. — Product Code GBW

K992907 is an FDA 510(k) premarket notification submitted by Taut, Inc. for the device "INTRADUCER". The FDA issued a decision of Substantially Equivalent on October 5, 1999. The device falls under product code GBW (Catheter, Peritoneal), a Class I device regulated under 21 CFR 878.4200. Taut, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 1999
Date Received
August 30, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Peritoneal
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

Other clearances by Taut, Inc.

  • K023261 — ADAPT BALLOON OPEN ACCESS PORT, MODEL 41244 (December 13, 2002)
  • K021731 — ADAPT OPEN ACCESS PORT, MODEL 41233 (August 8, 2002)
  • K011018 — TAUT BALLOON CATHETER, MODEL 50640 (June 22, 2001)
  • K010007 — ADAPT LAPAROSCOPIC PORT & ADAPT REDUCER CAP (February 22, 2001)
  • K003703 — TAUT-INSUFFLATION NEEDLE (February 22, 2001)
  • K992904 — MINI-PORT (October 5, 1999)
  • K972112 — INTRADUCER PORT SC CATALOG#31275,31035,30915, AND 31450 (December 1, 1997)
  • K962003 — TUAT SPLATTER CONTROL SHIELD SCS-300 (July 18, 1996)
  • K960883 — INTRADUCER PERITONEAL CATHETER 6FRX3, 9FRX3 1/2, 10FRX4, 12FRX8 (March 20, 1996)
  • K945486 — SPLATTER CONTROL SHIELD (February 28, 1995)

Other clearances for product code GBW

  • K992904 — MINI-PORT (October 5, 1999)
  • K972112 — INTRADUCER PORT SC CATALOG#31275,31035,30915, AND 31450 (December 1, 1997)
  • K961194 — ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN (August 8, 1996)
  • K960426 — MEDICOMP FLEXI-SMOOTH WOUND DRAINAGE CATHETER (March 21, 1996)
  • K942709 — MEDIASTINAL SILICONE DRAINS (January 4, 1996)
  • K933510 — ARGYLE TURKEL SAFETY TROCAR THORACIC CATHETER (February 24, 1994)
  • K926477 — BIFURCATED SUCTION/IRRIGAT TUBING SET W/PUSH BUTTO (November 12, 1993)
  • K913733 — STERILE CHEST TUBE (October 8, 1991)
  • K894220 — HOUTS HYSTERECTOMY DRAIN (August 24, 1989)
  • K894119 — MADEGOM LTDA. PENROSE DRAIN TUBING (August 18, 1989)

FDA data resources