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510(k) K051711

PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS by Denver Biomedical, Inc. — Product Code PNG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2005
Date Received
June 27, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type

For drainage of refractory ascites with long-term occurrence from the peritoneal cavity.

Other clearances by Denver Biomedical, Inc.

  • K052436 — PLEURX PLEURAL CATHETER KIT, MODEL 50-7000 (October 6, 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)

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