Heparin Cap, Injection Cap Male Luer-

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K841772 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Fluid Administrative Set, Afi

  Class II

  FDA 510(k) K820203 Active Cleared 5 Feb 1982

• Continuous Flush Device/Fdi

  Class II

  FDA 510(k) K820202 Active Cleared 12 Feb 1982

• Dispos. Monitoring Sys/Li Et Al

  Class II

  FDA 510(k) K820201 Active Cleared 12 Feb 1982

• Fluid Admin. Set Afs-1C

  Class II

  FDA 510(k) K831348 Active Cleared 27 May 1983

• What is the HEPARIN CAP used for?

  The HEPARIN CAP is an injection cap with a male Luer connector designed to attach to intravenous lines or catheters to maintain patency and prevent clotting by delivering heparinized solution.

• Is the HEPARIN CAP supplied sterile or non-sterile?

  The device data does not provide information regarding sterility, so it cannot be confirmed whether the HEPARIN CAP is supplied sterile or non-sterile based on the available details.

• Is the HEPARIN CAP intended for single-use or reuse?

  The HEPARIN CAP is supplied as a single-use component, meaning it is intended for one-time use and should not be reused after initial application.

• What regulatory pathway was used for the HEPARIN CAP?

  The HEPARIN CAP received FDA 510(k) clearance (K841772) on July 6, 1984, indicating it was cleared through the traditional 510(k) pathway as substantially equivalent to a predicate device.

• Are there different sizes or models of the HEPARIN CAP available?

  The device data does not specify any sizes, models, or reference numbers for the HEPARIN CAP, so no variations in size or model can be determined from the provided information.