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510(k) K240164

NovaLine SP-C35 Transducer Protector (956007) by Bain Medical Equipment (Guangzhou) Co., Ltd. — Product Code FIB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 2024
Date Received
January 22, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Protector, Transducer, Dialysis
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Bain Medical Equipment (Guangzhou) Co., Ltd.

  • K213015 — DORA Disposable A.V. Fistula Needle Sets (April 8, 2022)
  • K201866 — NovaLine Tubing Sets for Hemodialysis (March 10, 2021)
  • K203524 — Surgical Masks (February 25, 2021)
  • K163025 — DORA Disposable A.V. Fistula Needle Sets (July 20, 2017)
  • K161582 — DORA Tubing Sets for Hemodialysis (June 16, 2017)

Other clearances for product code FIB

  • K072988 — NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1 (February 21, 2008)
  • K001971 — HEMODIALYSIS TUBING SETS (May 24, 2001)
  • K010264 — NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING S (April 27, 2001)
  • K001465 — NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING S (December 5, 2000)
  • K003445 — FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2 (December 1, 2000)
  • K000702 — BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR (June 7, 2000)
  • K983076 — MEDISYSTEMS TRANSDUCER PROTECTOR (November 25, 1998)
  • K964337 — BETTER-BLADDER (BB) (May 23, 1997)
  • K970536 — MEDISYSTEMS TRANDUCER PROTECTOR (May 12, 1997)
  • K934069 — MILLEX, DUALEX (PLUS, ULTRA) (April 21, 1994)