Home / 510(k) Clearances / K812615

510(k) K812615

TM-CAPD by Tri-Med, Inc. — Product Code KPP

K812615 is an FDA 510(k) premarket notification submitted by Tri-Med, Inc. for the device "TM-CAPD". The FDA issued a decision of Substantially Equivalent on January 5, 1982. The device falls under product code KPP (Peritoneal Dialysate Filter), a Class II device regulated under 21 CFR 876.5630. Tri-Med, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 1982
Date Received
September 15, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Peritoneal Dialysate Filter
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type

Other clearances by Tri-Med, Inc.

  • K040112 — TRIMED BEARING PLATE; TRIMED VOLAR BEARING PLATE (March 12, 2004)
  • K030877 — TRIMED RADIAL BULLET (February 5, 2004)
  • K010545 — TBW (June 6, 2001)
  • K961863 — PARACENTESIS TRAYS (May 28, 1996)
  • K875224 — HUDSON CRANINAL BURRS (January 28, 1988)
  • K850745 — TRI-MED MODEL 112 MOISTURE TRAP (April 2, 1985)
  • K850746 — TRI-MED MODEL 126 SAMPLE LINE W/EXTENDED LIFE NAFI (April 2, 1985)
  • K850747 — TRI-MED MODEL 105 SPECIAL AIRWAY ADAPTOR (April 2, 1985)
  • K843681 — RESPIRATION & HEART RATE MONITOR 530 (December 4, 1984)
  • K843285 — TRI-MED 610 CAPNOSTAT GAS ANALYZER (November 13, 1984)

Other clearances for product code KPP

  • K803275 — KPP PERITONEAL DIALYSATE FILTER (March 13, 1981)
  • K800666 — QUIK-TEMP (May 8, 1980)

FDA data resources