Primed Tracheostomy Tubes (Multiple)
by Primed Halberstadt Medizintechnik GmbH
510(k) K120079
Primed Tracheostomy Tubes (Multiple) is a Class II device made by Primed Halberstadt Medizintechnik GmbH, cleared under FDA 510(k) K120079 on 24 May 2012, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK120079 | Date24 May 2012 | StatusActive |
Official records
- FDA 510(k) database K120079
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- BTO
- Device class
- Class II
- Regulation
- 21 CFR Part 868.5800
- Advisory committee
- Anesthesiology
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code BTO (Tube, Tracheostomy (W/Wo Connector)).
- SHILEY DISPOS CANNULA FENES LP CUFFED TRACHE TUBE by Shiley, Inc.
- SHILEY DISP. CANNULA CUFFLESS TRACEOSTOMY TUBE by Shiley, Inc.
- TRACHEOSTOMY CARE SET W/FORCEPS & GAUZE TRACH DRES by American Healthcare, Inc.
- TRACHEAL TUBES by Erie Medical
- WELL LEAD TRACHEOSTOMY TUBE by Well Lead Medical Instruments
- 15 mm Adaptor 310404 by Boston Medical Products, Inc.
- Venti-Trach Tracheostomy Tube (570 Series) by Vitaltec Corporation
- TRACHEOSTOMY TUBE AND CUFF by Concord/Portex
- TRACHEOSTOMY CARE KIT by Clinical Resources, Inc.
- CMI STOMA COVERS by Community Medical Center
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