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510(k) K913733

STERILE CHEST TUBE by Vascular Products, Inc. — Product Code GBW

K913733 is an FDA 510(k) premarket notification submitted by Vascular Products, Inc. for the device "STERILE CHEST TUBE". The FDA issued a decision of Substantially Equivalent on October 8, 1991. The device falls under product code GBW (Catheter, Peritoneal), a Class I device regulated under 21 CFR 878.4200. Vascular Products, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 1991
Date Received
August 20, 1991
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 Vascular Products, Inc.

  • K910840 — VASCULAR BIOPSY FORCEPS (July 15, 1991)
  • K823447 — IMPLANTABLE PACING LEAD, TINED #3262 & (December 3, 1982)

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)
  • K894220 — HOUTS HYSTERECTOMY DRAIN (August 24, 1989)
  • K894119 — MADEGOM LTDA. PENROSE DRAIN TUBING (August 18, 1989)

FDA data resources