KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBE
FDA 510(k) clearance K961977 · decided 1996-07-31
Clearance details
- K-number
- K961977
- Device name
- KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBE
- Applicant
- Kendall Healthcare Products Co. Div.Of Tyco Health
- Decision
- Substantially Equivalent
- Date received
- 1996-05-20
- Decision date
- 1996-07-31
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- CBI
- Device class
- 2
- Regulation number
- 868.5740
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mansfield, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Kendall Healthcare Products Co. Div.Of Tyco Health
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Left sided), Sizes: 28 Fr., 35 Fr. recall (Z-2367-2015) | Teleflex Medical | 2015-08-20 |
| Sheridan Sher-I-Bronch Endobronchial Tube, Left-Sided, 37 Fr, 26 mm tracheal cuff, 19 mm b recall (Z-0125-2007) | Teleflex Medical | 2006-11-02 |