CAPD Transfer Set Spike 5C4363

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K860230 ↗

FDA Product Code

KDJ

Device Class

Class II

Regulation

21 CFR Part 876.5630

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Burette Set with Air Control Lever

  Class II

  FDA 510(k) K780970 Active Cleared 27 Jul 1978

• Sterile Water & Saline in Plastic Btl.

  Class II

  FDA 510(k) K800753 Active Cleared 24 Apr 1980

• Solution Administration Sets

  Class II

  FDA 510(k) K860272 Active Cleared 18 Mar 1986

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• Blood-Solution Administration Set, Surg.

  Class I

  FDA 510(k) K760483 Active Cleared 3 Sep 1976

• Flo-Gard 8000 Computer Control Infusi

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  FDA 510(k) K834154 Active Cleared 25 Jan 1984

See all devices from Travenol Laboratories, S.A. →

• What is the CAPD Transfer Set Spike 5C4363 used for?

  The CAPD Transfer Set Spike 5C4363 is a disposable administration set specifically designed for use in continuous ambulatory peritoneal dialysis (CAPD) procedures. It facilitates the transfer of dialysis solution during peritoneal dialysis treatments.

• Is the CAPD Transfer Set Spike 5C4363 a single-use device?

  Yes, the CAPD Transfer Set Spike 5C4363 is supplied as a single-use device and is not intended for reuse. This design ensures patient safety and prevents cross-contamination between dialysis sessions.

• What is the regulatory classification of this device?

  The CAPD Transfer Set Spike 5C4363 is classified as a Class II medical device under product code KDJ with special controls. It received FDA 510(k) clearance on February 5, 1986, with the K number K860230.

• What medical specialties is this device associated with?

  The CAPD Transfer Set Spike 5C4363 is associated with the medical specialties of gastroenterology and urology, reflecting its application in peritoneal dialysis procedures which fall within these practice areas.