Last synced on 14 June 2024 at 11:05 pm

Apparatus, Suction, Patient Care

Page Type
Product Code
Regulation Medical Specialty
Cardiovascular
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
870.5050
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 870.5050 Patient care suction apparatus

§ 870.5050 Patient care suction apparatus.

(a) Identification. A patient care suction apparatus is a device used with an intrathoracic catheter to withdraw fluid from the chest during the recovery period following surgery.

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

Apparatus, Suction, Patient Care

Page Type
Product Code
Regulation Medical Specialty
Cardiovascular
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
870.5050
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 870.5050 Patient care suction apparatus

§ 870.5050 Patient care suction apparatus.

(a) Identification. A patient care suction apparatus is a device used with an intrathoracic catheter to withdraw fluid from the chest during the recovery period following surgery.

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