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510(k) K901996

FILTERTEK PN 60650 DIALYSIS TRANSDUCER PROTECTOR by Filtertek, Inc. — Product Code FIB

K901996 is an FDA 510(k) premarket notification submitted by Filtertek, Inc. for the device "FILTERTEK PN 60650 DIALYSIS TRANSDUCER PROTECTOR". The FDA issued a decision of Substantially Equivalent on June 1, 1990. The device falls under product code FIB (Protector, Transducer, Dialysis), a Class II device regulated under 21 CFR 876.5820. Filtertek, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 1990
Date Received
May 2, 1990
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 Filtertek, Inc.

  • K981548 — NFC NEEDLEFREE CONNECTOR MODEL 69900 (June 18, 1998)
  • K981547 — NFC NEEDLEFREE Y-SITE, MODEL 69970 (June 18, 1998)
  • K914792 — PN 62290 0.22 MICRON MICRO INFUS I.V. EXTEN SET (January 15, 1992)
  • K912848 — I.V. FILTER EXTENSION SET (November 29, 1991)
  • K912394 — TRANSDUCER PROTECTOR (August 30, 1991)
  • K911451 — I.V. EXTENDER SET (June 6, 1991)
  • K904912 — TRANSDUCER PROTECTOR (January 4, 1991)
  • K901409 — TRANSDUCER PROTECTOR (July 27, 1990)
  • K895281 — TRANSDUCER PROTECTOR (November 8, 1989)

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