Cardiovascular Spring Guide Wire

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

510(k) Number

K834223 ↗

FDA Product Code

DQX

Device Class

Class II

Regulation

21 CFR Part 870.1330

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Foam Nose

  Class I

  FDA 510(k) K840399 Active Cleared 16 Mar 1984

• Isotonic Diluent

  Class I

  FDA 510(k) K781008 Active Cleared 28 Jun 1978

• Hi-Lo Temp Thermocouple to Thermister Adaptor

  Class II

  FDA 510(k) K844201 Active Cleared 4 Mar 1985

• Glucose Reagent (O-Toluidine)

  Class II

  FDA 510(k) K771314 Active Cleared 3 Aug 1977

• Ria Quant C-Peptide Kit

  Class I

  FDA 510(k) K812689 Active Cleared 6 Oct 1981

• Hi-Lo Temp(R) Model 8700 Patient Temp Monitor

  Class II

  FDA 510(k) K874568 Active Cleared 6 Jan 1988

See all devices from Mallinckrodt Critical Care →

• What is the Cardiovascular Spring Guide Wire used for?

  The Cardiovascular Spring Guide Wire is designed to assist in cardiovascular procedures such as angioplasty or stenting. Its spring-loaded mechanism helps guide catheters or other interventional devices through coronary or peripheral arteries, improving precision during placement.

• Is the Cardiovascular Spring Guide Wire sterile?

  No, the Cardiovascular Spring Guide Wire is supplied as a non-sterile instrument. It is intended for single-use only, so proper sterilization before use is not applicable. Users should follow standard aseptic techniques when handling the device.

• How is the Cardiovascular Spring Guide Wire supplied?

  The device is supplied as a single-use item, meaning it is intended for one-time use only. This design minimizes the risk of cross-contamination and ensures patient safety. The packaging should be inspected for integrity before use.

• What regulatory pathway was used for FDA clearance?

  The Cardiovascular Spring Guide Wire was cleared via a Traditional 510(k) pathway by the FDA in 1984. It was reviewed by the Cardiovascular Advisory Committee and deemed substantially equivalent (SESE) to a predicate device, meaning it shares the same intended use and technological characteristics as the original.

• Are there different sizes or models available for this guide wire?

  The provided regulatory data does not specify multiple sizes or models for the Cardiovascular Spring Guide Wire. However, the spring-loaded design suggests it may offer flexibility in navigating various arterial pathways. For exact specifications, refer to the manufacturer’s product documentation or contact Mallinckrodt Critical Care.