MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003
Device Facts
| Record ID | K111488 |
|---|---|
| Device Name | MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003 |
| Applicant | Bridgepoint Medical |
| Product Code | DQX · Cardiovascular |
| Decision Date | Jun 30, 2011 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 870.1330 |
| Device Class | Class 2 |
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.
