Home / 510(k) Clearances / K052436

510(k) K052436

PLEURX PLEURAL CATHETER KIT, MODEL 50-7000 by Denver Biomedical, Inc. — Product Code DWM

K052436 is an FDA 510(k) premarket notification submitted by Denver Biomedical, Inc. for the device "PLEURX PLEURAL CATHETER KIT, MODEL 50-7000". The FDA issued a decision of Substantially Equivalent on October 6, 2005. The device falls under product code DWM (Apparatus, Suction, Patient Care), a Class II device regulated under 21 CFR 870.5050. Denver Biomedical, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 2005
Date Received
September 6, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Patient Care
Device Class
Class II
Regulation Number
870.5050
Review Panel
AN
Submission Type

Other clearances by Denver Biomedical, Inc.

  • K051711 — PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS (November 15, 2005)
  • K012235 — DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PU (October 4, 2001)
  • K011862 — DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT (July 12, 2001)
  • K011831 — MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS (June 28, 2001)

Other clearances for product code DWM

  • K212696 — Aspira Pleural Drainage System (March 3, 2023)
  • K210509 — Rocket Platinum Cured Cathter (September 9, 2021)
  • K201404 — Passio Pump Drainage System (November 20, 2020)
  • K190292 — Passio Pump Drainage System (July 25, 2019)
  • K163321 — Rocket Indwelling Pleural Catheter (IPC) Insertion Kit (August 17, 2017)
  • K160450 — Pleurx Pleural Catheter System (October 31, 2016)
  • K141965 — PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT (July 2, 2015)
  • K123033 — ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PA (February 1, 2013)
  • K121849 — PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSE (October 18, 2012)
  • K112831 — PLEURX PLEURAL CATHETER SYSTEMS (February 16, 2012)

FDA data resources