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Catheter, Neuro-Vasculature, Occluding Balloon

Page Type
Product Code
Definition
Used to obstruct lower aortic blood flow to augment cerebral perfusion.
Physical State
A multi-lumen catheter with two balloons mounted near the distal tip
Technical Method
Temporary balloon inflation in the descending aortic artery obstructs or redirect blood flow
Target Area
Double balloon catheter deployed in the descending aortic artery and hypothesized to increase cerebral blood flow
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
HDE - Humanitarian Device Exemption
Device Classification
F
Regulation Number
882.5150
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.5150 Intravascular occluding catheter

§ 882.5150 Intravascular occluding catheter.

(a) Identification. An intravascular occluding catheter is a catheter with an inflatable or detachable balloon tip that is used to block a blood vessel to treat malformations, e.g., aneurysms (balloonlike sacs formed on blood vessels) of intracranial blood vessels.

(b) Classification. Class III (premarket approval).

(c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any intravascular occluding catheter that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to an intravascular occluding catheter that was in commercial distribution before May 28, 1976. Any other intravascular occluding catheter shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

[44 FR 51730, Sept. 4, 1979, as amended at 52 FR 17740, May 11, 1987; 61 FR 50708, Sept. 27, 1996]

Catheter, Neuro-Vasculature, Occluding Balloon

Page Type
Product Code
Definition
Used to obstruct lower aortic blood flow to augment cerebral perfusion.
Physical State
A multi-lumen catheter with two balloons mounted near the distal tip
Technical Method
Temporary balloon inflation in the descending aortic artery obstructs or redirect blood flow
Target Area
Double balloon catheter deployed in the descending aortic artery and hypothesized to increase cerebral blood flow
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
HDE - Humanitarian Device Exemption
Device Classification
F
Regulation Number
882.5150
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.5150 Intravascular occluding catheter

§ 882.5150 Intravascular occluding catheter.

(a) Identification. An intravascular occluding catheter is a catheter with an inflatable or detachable balloon tip that is used to block a blood vessel to treat malformations, e.g., aneurysms (balloonlike sacs formed on blood vessels) of intracranial blood vessels.

(b) Classification. Class III (premarket approval).

(c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any intravascular occluding catheter that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to an intravascular occluding catheter that was in commercial distribution before May 28, 1976. Any other intravascular occluding catheter shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

[44 FR 51730, Sept. 4, 1979, as amended at 52 FR 17740, May 11, 1987; 61 FR 50708, Sept. 27, 1996]