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510(k) K011831

MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS by Denver Biomedical, Inc. — Product Code DWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 2001
Date Received
June 12, 2001
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)
  • 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)

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