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510(k) K010642

PLEURX PLEURAL CATHETER AND DRAINAGE KITS by Denver Biomedicals, Inc. — Product Code DWM

K010642 is an FDA 510(k) premarket notification submitted by Denver Biomedicals, Inc. for the device "PLEURX PLEURAL CATHETER AND DRAINAGE KITS". The FDA issued a decision of Substantially Equivalent on March 20, 2001. The device falls under product code DWM (Apparatus, Suction, Patient Care), a Class II device regulated under 21 CFR 870.5050. Denver Biomedicals, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2001
Date Received
March 5, 2001
Clearance Type
Traditional
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 Biomedicals, Inc.

  • K051084 — DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINE (June 13, 2005)
  • K011020 — DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER (June 1, 2001)
  • K003451 — DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHU (January 2, 2001)
  • K943968 — TUNNELER (March 1, 1995)
  • K913728 — DENVER(R) PERITONEO-SUBCLAVIAN SHUNT (February 18, 1994)
  • K842139 — THE DENVER PLEURAL-PERITONEAL SHUNT (August 27, 1984)
  • K822686 — DENVER PERITONEO-VENOUS SHUNT (DP-VS) (September 21, 1982)
  • K811577 — CROUCH CORNEAL PROTECTOR (August 7, 1981)
  • K811183 — DENVER PERITONEO-VENOUS SHUNT (July 1, 1981)

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