Last synced on 24 June 2022 at 11:05 pm

Non-Bronchoscopic Bronchoalveolar Lavage Catheter

Page Type
Product Code
Definition
To perform non-bronchoscopic bronchoalveolar lavage (bal) in adult patients undergoing mechanical ventilation.
Physical State
This device is a catheter
Technical Method
The device is inserted into a patient's lungs to collect bronchoalveolar labage specimens
Target Area
Lungs
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
868.6810
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 868.6810 Tracheobronchial suction catheter

§ 868.6810 Tracheobronchial suction catheter.

(a) Identification. A tracheobronchial suction catheter is a device used to aspirate liquids or semisolids from a patient's upper airway.

(b) Classification. Class 1 (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 868.9.

[47 FR 31142, July 16, 1982, as amended at 65 FR 2314, Jan. 14, 2000]

Non-Bronchoscopic Bronchoalveolar Lavage Catheter

Page Type
Product Code
Definition
To perform non-bronchoscopic bronchoalveolar lavage (bal) in adult patients undergoing mechanical ventilation.
Physical State
This device is a catheter
Technical Method
The device is inserted into a patient's lungs to collect bronchoalveolar labage specimens
Target Area
Lungs
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
868.6810
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 868.6810 Tracheobronchial suction catheter

§ 868.6810 Tracheobronchial suction catheter.

(a) Identification. A tracheobronchial suction catheter is a device used to aspirate liquids or semisolids from a patient's upper airway.

(b) Classification. Class 1 (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 868.9.

[47 FR 31142, July 16, 1982, as amended at 65 FR 2314, Jan. 14, 2000]