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510(k) K812772

PERITONEAL DIALYSIS CYCLER SET (8UNIT) by Dravon Medical, Inc. — Product Code KDJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 1981
Date Received
October 5, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, For Peritoneal Dialysis, Disposable
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type

Other clearances by Dravon Medical, Inc.

  • K873455 — S3086 ARTERIAL, S3087 VENOUS NEONATAL HEMODIALYSIS (September 14, 1987)
  • K860770 — AM-100 I/A AMPAC (April 21, 1986)
  • K832739 — STEDIFLO INFUSION SET (December 22, 1983)
  • K831842 — DRAVON T CLAMP (September 26, 1983)
  • K812771 — PERITONEAL DIALYSIS DRAINAGE (October 19, 1981)
  • K811851 — S-610 SHUNT ADAPTOR SET (August 31, 1981)
  • K800435 — HEMOSTATIC/TUBE OCCLUDING FORCEPS (March 12, 1980)
  • K782058 — CATHETER, BETA-CAP-PERITONEAL (February 27, 1979)
  • K782057 — CATHETER, RADIOPAQUE TENCKHOFF (February 27, 1979)
  • K781755 — DAP-PAK (February 15, 1979)

Other clearances for product code KDJ

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  • K231849 — MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap E (March 12, 2024)
  • K214016 — 15L Cycler Drainage Bag (March 18, 2022)
  • K192705 — MiniCap Extended Life PD Transfer Sets (October 25, 2019)
  • K173593 — stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter ext (May 21, 2018)
  • K173651 — Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set (February 14, 2018)
  • K173363 — Cycler Drain Bag Set (January 24, 2018)
  • K151620 — Firefly Peritoneal Dialysis Connector Disinfection System (January 20, 2016)
  • K152129 — FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iod (October 29, 2015)
  • K152675 — EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER A (October 29, 2015)