Trap-Blood Vessel Stabilization Device
by Ayer, Patrick, M.D. 510(k)
Active
510(k) K781072
Overview
This device is a Blood Vessel Stabilization Device designed to immobilize and secure a blood vessel, particularly an artery, during puncture procedures. It ensures precise and stable access by maintaining positional integrity, reducing movement and improving procedural accuracy.
The device consists of a first member held against the skin via an elastic band encircling the patient’s wrist, positioned transversely relative to the artery. It features projecting leg members that engage the skin on opposite sides of the vessel, providing mechanical stabilization. Supplied as a reusable medical instrument, it is intended for use in clinical chemistry settings and has received FDA 510(k) clearance under product code JIT. No additional regulatory markings or sterility requirements are specified.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK781072 | Date10 Aug 1978 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
- JIT
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1150
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Questions
What is the primary purpose of the TRAP-BLOOD VESSEL STABILIZATION DEVICE, and where is it typically used?
The TRAP-BLOOD VESSEL STABILIZATION DEVICE is designed to immobilize and secure an artery during puncture procedures, ensuring precise and stable access. It is specifically intended for use in clinical chemistry settings, where maintaining positional integrity of the vessel reduces movement and improves procedural accuracy.
Is the TRAP-BLOOD VESSEL STABILIZATION DEVICE intended for single-use or reusable applications?
The device is explicitly described as a reusable medical instrument. It is not packaged or labeled for single-use, and no sterility requirements are specified, indicating it is meant for repeated use in clinical settings.
How does the device physically secure a blood vessel during procedures?
The device features a first member held against the skin via an elastic band encircling the patient’s wrist, positioned transversely relative to the artery. It also includes projecting leg members that engage the skin on opposite sides of the vessel, mechanically stabilizing it and preventing movement during punctures.
What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?
The device received FDA 510(k) clearance under product code JIT, with a substantially equivalent determination by the Clinical Chemistry (CH) Advisory Committee. This means it was deemed comparable to a legally marketed predicate device and is authorized for use in clinical chemistry procedures, particularly for stabilizing vessels during punctures.
Are there any special storage requirements for the TRAP-BLOOD VESSEL STABILIZATION DEVICE?
The device data does not specify any unique storage requirements beyond standard reusable medical instrument protocols. Since it is reusable and not sterile, it should be cleaned, disinfected, and stored according to clinical chemistry facility protocols to maintain functionality and hygiene between uses.