Last synced on 6 December 2024 at 11:05 pm

System, Catheter Or Guidewire, Steerable (Magnetic)

Page Type
Product Code
Regulation Medical Specialty
Cardiovascular
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
870.1290
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 870.1290 Steerable catheter control system

§ 870.1290 Steerable catheter control system.

(a) Identification. A steerable catheter control system is a device that is connected to the proximal end of a steerable guide wire that controls the motion of the steerable catheter.

(b) Classification. Class II (performance standards).

System, Catheter Or Guidewire, Steerable (Magnetic)

Page Type
Product Code
Regulation Medical Specialty
Cardiovascular
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
870.1290
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 870.1290 Steerable catheter control system

§ 870.1290 Steerable catheter control system.

(a) Identification. A steerable catheter control system is a device that is connected to the proximal end of a steerable guide wire that controls the motion of the steerable catheter.

(b) Classification. Class II (performance standards).