Last synced on 24 June 2022 at 11:05 pm

Tube, Tracheal, Reprocessed

Page Type
Product Code
Definition
Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.5730
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
Yes
Third Party Review
Not Third Party Eligible

CFR § 868.5730 Tracheal tube

§ 868.5730 Tracheal tube.

(a) Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.

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

Tube, Tracheal, Reprocessed

Page Type
Product Code
Definition
Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.5730
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
Yes
Third Party Review
Not Third Party Eligible

CFR § 868.5730 Tracheal tube

§ 868.5730 Tracheal tube.

(a) Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.

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