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510(k) K970536

MEDISYSTEMS TRANDUCER PROTECTOR by Medisystems Corp. — Product Code FIB

K970536 is an FDA 510(k) premarket notification submitted by Medisystems Corp. for the device "MEDISYSTEMS TRANDUCER PROTECTOR". The FDA issued a decision of Substantially Equivalent on May 12, 1997. The device falls under product code FIB (Protector, Transducer, Dialysis), a Class II device regulated under 21 CFR 876.5820. Medisystems Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 1997
Date Received
February 12, 1997
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 Medisystems Corp.

  • K062953 — MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEEDLE SET WITH SECUREMENT DEVICE (February 12, 2007)
  • K010279 — MEDISYSTEMS LUER ACCESS INJECTION SITE (May 29, 2001)
  • K002372 — ACCESS ALERT GAUGE (October 25, 2000)
  • K994306 — REVERSO (March 20, 2000)
  • K990803 — MEDISYSTEMS BUTTONHOLE NEEDLE SETS (January 6, 2000)
  • K983076 — MEDISYSTEMS TRANSDUCER PROTECTOR (November 25, 1998)
  • K971860 — MEDISYSTEMS DIALYSIS PRIMING SETS (August 18, 1997)
  • K963668 — MEDISYSTEMS PERITONEAL DIALYSIS SETS (August 15, 1997)
  • K953823 — ARTERIAL VENOUS BLOOD TUBING SET (September 23, 1996)
  • K932074 — MEDISYSTEMS APHERESIS NEEDLE WITH GUARD (February 18, 1994)

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)
  • K934069 — MILLEX, DUALEX (PLUS, ULTRA) (April 21, 1994)

FDA data resources