21 CFR 870.1330 — Wire, Guide, Catheter
Cardiovascular (CV) · Part 870 Subpart B—Cardiovascular Diagnostic Devices · § 870.1330
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DQX | Wire, Guide, Catheter | 2 | 763 | 3rd Party |
| MOF | Guide, Wire, Catheter, Neurovasculature | 2 | 39 | 3rd Party |
| NKQ | Guidewire, Catheter, Reprocessed | 2 | 0 | |
| OFB | Catheter Guide Wire Kit | 2 | 0 | |
| PTL | Wire, Guide, Catheter, Exempt | 2 | 0 |
Special Controls
DQX — Wire, Guide, Catheter
*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.
eCFR
MOF — Guide, Wire, Catheter, Neurovasculature
*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.
eCFR
NKQ — Guidewire, Catheter, Reprocessed
*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.
eCFR
OFB — Catheter Guide Wire Kit
*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.
eCFR
PTL — Wire, Guide, Catheter, Exempt
*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.
eCFR
