CORDIS STABILIZER PLUS XS
Device Facts
| Record ID | K962932 |
|---|---|
| Device Name | CORDIS STABILIZER PLUS XS |
| Applicant | Cordis Corp. |
| Product Code | DQX · Cardiovascular |
| Decision Date | Oct 25, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1330 |
| Device Class | Class 2 |
Intended Use
The Cordis STABILIZER Plus XS Steerable Guidewires are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.
Device Story
Steerable guidewire; extra support version of WIZDOM guidewire. Input: manual manipulation by physician during angiographic procedures. Function: provides structural support for introduction of interventional devices (e.g., stents) into coronary/peripheral vasculature. Output: physical guidance/pathway for catheters. Used in clinical/interventional settings; operated by physicians. Benefit: facilitates delivery of bulky interventional devices.
Clinical Evidence
No clinical data; bench testing only.
Technological Characteristics
Steerable guidewire; utilizes larger diameter corewires and modified tapers compared to conventional WIZDOM guidewire for increased support. Materials identical to predicate WIZDOM guidewire. Class II device (21 CFR 870.1330).
Indications for Use
Indicated for use in angiographic procedures to facilitate introduction and positioning of catheters and interventional devices within coronary and peripheral vasculature.
Regulatory Classification
Identification
A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.
Special Controls
*Classification.* Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Predicate Devices
- Cordis WIZDOM Steerable Guidewire (K953760)
- Meditech/Boston Scientific Platinum Plus™ Guidewire (K935997)
- Scimed/Boston Scientific Platinum Plus™ Coronary Guidewire
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- K955637 — ESSENCE GUIDEWIRE · Cordis Neurovascular, Inc. · Mar 11, 1996
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