TRACHEOSTOMY CARE KIT (STERILE)
FDA 510(k) clearance K925020 · decided 1993-07-07
Clearance details
- K-number
- K925020
- Device name
- TRACHEOSTOMY CARE KIT (STERILE)
- Applicant
- Customed, Inc.
- Decision
- Unknown
- Date received
- 1992-09-24
- Decision date
- 1993-07-07
- Days to decision
- 286 days
- Clearance type
- Traditional
- Product code
- JOH
- Device class
- 2
- Regulation number
- 868.5800
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Fajardo, PR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Catalog Number: 900110 TRACHEOSTOMY CARE KIT WITH TRACH TUBE HOLDER FOR ADULT Used by medi recall (Z-1411-2016) | Customed, Inc | 2016-04-14 |
| TRACHEOTOMY CARE KIT CUSTOMED 50/CS Used by medical staff to perform surgical procedures a recall (Z-2565-2015) | Customed, Inc | 2015-09-03 |
| Tracheotomy care kit, catalog# 900-110 recall (Z-1255-2012) | Customed, Inc | 2012-03-21 |