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510(k) K894119

MADEGOM LTDA. PENROSE DRAIN TUBING by Madegom — Product Code GBW

K894119 is an FDA 510(k) premarket notification submitted by Madegom for the device "MADEGOM LTDA. PENROSE DRAIN TUBING". The FDA issued a decision of Substantially Equivalent on August 18, 1989. The device falls under product code GBW (Catheter, Peritoneal), a Class I device regulated under 21 CFR 878.4200. Madegom has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 1989
Date Received
June 12, 1989
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 Madegom

  • K894120 — MADEGOM LTDA. DENTAL DAM (August 21, 1989)

Other clearances for product code GBW

  • K992904 — MINI-PORT (October 5, 1999)
  • K992907 — INTRADUCER (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)

FDA data resources