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510(k) K863496

MEDIFLEX TRANSDUCER PROTECTOR by Mediflex Intl. — Product Code FIB

K863496 is an FDA 510(k) premarket notification submitted by Mediflex Intl. for the device "MEDIFLEX TRANSDUCER PROTECTOR". The FDA issued a decision of Substantially Equivalent on September 23, 1986. The device falls under product code FIB (Protector, Transducer, Dialysis), a Class II device regulated under 21 CFR 876.5820. Mediflex Intl. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1986
Date Received
September 9, 1986
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 Mediflex Intl.

  • K915140 — PRIMARY DRESSING TRAY (February 11, 1992)
  • K900841 — HEMODIALYSIS TRANSDUCER PROTECTOR (May 15, 1990)
  • K891077 — MEDIVERSE PARENTERAL NUTRITION BAG (May 24, 1989)
  • K884243 — BLOOD TUBING SET (December 8, 1988)
  • K855039 — MEDIFLEX INJECTION CAP (January 24, 1986)
  • K854346 — MEDIFLEX DISPOSABLE TUBING CLAMP (November 18, 1985)
  • K852106 — I.V. ADMINISTRATION SET (June 7, 1985)
  • K843126 — MEDIFLEX DRAINAGE BAG (October 4, 1984)

Other clearances for product code FIB

  • K240164 — NovaLine SP-C35 Transducer Protector (956007) (June 28, 2024)
  • 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)

FDA data resources