Air-Band Radial Compression Device
by Datascope Corp., Cardiac Assist Division 510(k)
Active
510(k) K122405
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK122405 | Date9 Nov 2012 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DXC
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.4450
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Air-Band Radial Compression Device is a vascular clamp designed to assist in hemostasis of the radial artery. It applies controlled compression to the artery post-procedure to prevent bleeding, ensuring stable access during transradial interventions. This device is classified under product code DXC as a Class 2 Cardiovascular device, adhering to regulatory standards for vascular control.
This device is supplied as a single-use, sterile instrument intended for use in clinical settings such as cardiac catheterization labs. It is regulated under FDA 510(k) clearance (K122405) and follows the Traditional 510(k) review pathway. Storage and handling must comply with sterile medical device protocols to maintain integrity before use. No additional MRI safety or reusable specifications are noted in the regulatory data.
Other devices from Datascope Corp., Cardiac Assist Division
Questions
AI-generated answers, 1 Oct 2026
What is the Air-Band Radial Compression Device used for?
The Air-Band Radial Compression Device is designed to assist in hemostasis of the radial artery after procedures like transradial interventions. It applies controlled compression to the artery to prevent bleeding, ensuring stable access and reducing the risk of complications during the procedure. This helps clinicians maintain vascular control efficiently in cardiac catheterization labs.
Is the Air-Band Radial Compression Device single-use or reusable?
The Air-Band Radial Compression Device is intended for single-use only. This classification aligns with standard sterile medical device protocols to ensure patient safety and prevent cross-contamination. After use, the device must be discarded according to clinical waste guidelines.
How should the Air-Band Radial Compression Device be stored?
The device must be stored following sterile medical device protocols to maintain its integrity before use. This includes keeping it in its original packaging, in a clean, dry environment, and away from direct sunlight or extreme temperatures. Proper storage ensures sterility and functionality when needed for procedures.
What regulatory pathway does the Air-Band Radial Compression Device follow?
The Air-Band Radial Compression Device is regulated under the FDA’s Traditional 510(k) review pathway and holds FDA 510(k) clearance (K122405). This clearance confirms that the device is substantially equivalent to a legally marketed predicate device, meeting regulatory standards for Class 2 Cardiovascular devices under product code DXC.
Does the Air-Band Radial Compression Device have any special handling requirements?
Beyond standard sterile medical device protocols, the Air-Band Radial Compression Device does not have additional handling requirements such as MRI safety considerations or reusable processing. It is supplied sterile and intended for immediate single-use in clinical settings, so adherence to sterile field practices is critical before and during use.