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510(k) K853536

VELCRO FISTULA PRESSURE CLAMPS by Cp Medical — Product Code KXM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 1985
Date Received
August 23, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System Accessories, Extracorporeal
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Cp Medical

  • K173922 — C-PTFETM Surgical Suture (March 26, 2018)
  • K094028 — CP-FIBER (ORTHOFIBER) (March 18, 2010)
  • K072229 — MONOSWIFT (October 5, 2007)
  • K071550 — PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS (July 18, 2007)
  • K060987 — OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31 (November 2, 2006)
  • K041894 — ORTHOFIBER (September 17, 2004)
  • K034062 — CP SLEEVE AND RIVER SLEEVE (January 30, 2004)
  • K024372 — CP MEDICAL BONE WAX (June 19, 2003)
  • K030786 — MONO-SWIFT (May 6, 2003)
  • K030351 — STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE (March 28, 2003)

Other clearances for product code KXM

  • K925581 — BAXTER BIOSTAT 1000 UREA MONITOR (May 3, 1995)
  • K863471 — COLORADO MEDICAL MODEL PTC 1000 (October 2, 1986)
  • K831402 — PRESSURE MONITOR & CONTROL UNIT APC-02A (August 8, 1983)