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510(k) K211894

Trachealator by Disa Medinotec — Product Code KTI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 2021
Date Received
June 21, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bronchoscope Accessory
Device Class
Class II
Regulation Number
874.4680
Review Panel
EN
Submission Type

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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  • K222187 — Multistage Balloon Dilatation Catheter (March 1, 2023)