Last synced on 5 July 2024 at 11:05 pm

Catheter, Percutaneous, Neurovasculature

Page Type
Product Code
Definition
To provide vascular access to the neurovasculature for interventional or diagnostic procedures
Physical State
Percutaneous catheter for neurovasculature
Technical Method
Uses a catheter to provide access to the neurovasculature for interventional or diagnostic procedures
Target Area
Neurovasculature
Regulation Medical Specialty
Cardiovascular
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
870.1250
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 870.1250 Percutaneous catheter

§ 870.1250 Percutaneous catheter.

(a) Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

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

Catheter, Percutaneous, Neurovasculature

Page Type
Product Code
Definition
To provide vascular access to the neurovasculature for interventional or diagnostic procedures
Physical State
Percutaneous catheter for neurovasculature
Technical Method
Uses a catheter to provide access to the neurovasculature for interventional or diagnostic procedures
Target Area
Neurovasculature
Regulation Medical Specialty
Cardiovascular
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
870.1250
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 870.1250 Percutaneous catheter

§ 870.1250 Percutaneous catheter.

(a) Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

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