RUSCH ULTRA TRACHEOFLEX FENESTRATED KIT CUFFED,UNCUFFED/ RUSCH TRACHEOFLEX TRACHEOSTOMY KIT UNCUFFED STERILE
FDA 510(k) clearance K964056 · decided 1997-10-10
Clearance details
- K-number
- K964056
- Device name
- RUSCH ULTRA TRACHEOFLEX FENESTRATED KIT CUFFED,UNCUFFED/ RUSCH TRACHEOFLEX TRACHEOSTOMY KIT UNCUFFED STERILE
- Applicant
- Rusch Intl.
- Decision
- Substantially Equivalent
- Date received
- 1996-10-09
- Decision date
- 1997-10-10
- Days to decision
- 366 days
- Clearance type
- Traditional
- Product code
- JOH
- Device class
- 2
- Regulation number
- 868.5800
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Jeffrey, NH, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Rusch Intl.
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 |
|---|---|---|
| Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patients, particularl recall (Z-0044-2017) | Teleflex Medical | 2016-10-18 |