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510(k) K964337

BETTER-BLADDER (BB) by Circulatory Technology, Inc. — Product Code FIB

K964337 is an FDA 510(k) premarket notification submitted by Circulatory Technology, Inc. for the device "BETTER-BLADDER (BB)". The FDA issued a decision of Substantially Equivalent on May 23, 1997. The device falls under product code FIB (Protector, Transducer, Dialysis), a Class II device regulated under 21 CFR 876.5820. Circulatory Technology, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1997
Date Received
October 31, 1996
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 Circulatory Technology, Inc.

  • K140321 — INITARY BETTER BLADDER-PEDIATRIC (April 17, 2014)
  • K012942 — THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, C (November 5, 2001)
  • K001822 — THE V-BAG (July 7, 2000)
  • K981284 — BETTER-BLADDER (BB) (August 12, 1998)
  • K964205 — BETTER-TUBING (April 8, 1998)
  • K961594 — BETTER-VENTER (September 5, 1996)
  • K941492 — PRESSURE RELIEF VALVE (October 26, 1994)
  • K942933 — PRESSURE INFUSION CUFF (August 25, 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)
  • K970536 — MEDISYSTEMS TRANDUCER PROTECTOR (May 12, 1997)
  • K934069 — MILLEX, DUALEX (PLUS, ULTRA) (April 21, 1994)

FDA data resources