AMT Bridle - Nasal Tube Retention System
FDA 510(k) clearance K142971 · decided 2015-05-26
Clearance details
- K-number
- K142971
- Device name
- AMT Bridle - Nasal Tube Retention System
- Applicant
- Applied Medical Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-10-14
- Decision date
- 2015-05-26
- Days to decision
- 224 days
- Clearance type
- Traditional
- Product code
- KNT
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Brecksville, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AMT Bridle - Nasal Tube Retaining System Used with Nasogastric/Nasointestinal (NG/NI) tube recall (Z-1223-2017) | Applied Medical Technology Inc | 2017-02-17 |
| AMT 12 inch Right Angle Feeding Set with Y-Port Used with Nasogastric/Nasointestinal (NG/N recall (Z-1224-2017) | Applied Medical Technology Inc | 2017-02-17 |