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510(k) K101261

CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 by C.R. Bard, Inc. — Product Code NFK

K101261 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000". The FDA issued a decision of Substantially Equivalent on July 29, 2010. The device falls under product code NFK (Kit, Repair, Catheter, Hemodialysis), a Class II device regulated under 21 CFR 876.5540. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2010
Date Received
May 5, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Repair, Catheter, Hemodialysis
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
Submission Type

Hemodialysis Tray

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  • K252971 — Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (La (March 17, 2026)
  • K251864 — Rubber Utility Catheter (February 23, 2026)
  • K251186 — Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) (May 15, 2025)
  • K241334 — Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Elec (January 31, 2025)
  • K230356 — Aspirex™ Thrombectomy System (March 31, 2023)
  • K223177 — Highlander™ 014 PTA Balloon Dilatation Catheter (January 20, 2023)
  • K222793 — WavelinQ™ Generator (October 17, 2022)
  • K220270 — Aspirex Thrombectomy System (June 21, 2022)

Other clearances for product code NFK

  • K092797 — ACUTE AND CHRONIC CATHETER REPAIR KIT (November 19, 2009)
  • K063446 — CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 (December 15, 2006)
  • K062435 — REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS (December 5, 2006)
  • K030442 — CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 (July 21, 2003)
  • K022644 — RETRO REPAIR KIT, MODEL PRRK5 (November 6, 2002)
  • K022570 — MEDCOMP REPAIR KIT, MODEL ASPCRPK (October 31, 2002)
  • K022561 — CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 (August 23, 2002)
  • K020430 — DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK) (May 9, 2002)
  • K011015 — CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 (June 22, 2001)
  • K011576 — MEDCOMP ASH SPLIT (June 21, 2001)

FDA data resources