510(k) K951091
- Device
- RUSCH ENDOBRONCHIAL TUBE SETS
- Applicant
- RUSCH INTL.
- 510(k) number
- K951091
- Product code
- BTS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-06-08
- Date received
- 1995-03-09
- Regulation
- 868.5720
- Classification name
- Tube, Bronchial (w/wo Connector)
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- NEIL R ARMSTRONG
- Address
- Tall Pines Park Jeffrey NH US 03452 03452
FDA Registration Numbers#
- 3002807314
- 3003898360
- 3014656749
- 3018094310
- 3002807561
- 1820334
- 8020889
- 3011137372
- 3004365956
- 2936999
Source Documents#
Other 510(k) Records For Product Code BTS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K953963 | RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIAL INTUBATION | Rusch, Inc. | 1995-11-27 |
| K902116 | MODIFIED ENDOBRONCHIAL TUBE | Concord/Portex | 1990-08-03 |
| K834565 | ENDOBRONCHIAL TWIN LUMEN TUBE | Portex, Inc. | 1984-01-17 |
| K833297 | BRONCHOSCOPY TUBE W/ULTRA LOCUFF | Surgitek | 1983-12-27 |
| K771219 | BRONCHO-CATH | Mallinckrodt Critical Care | 1977-08-04 |
Legacy Summary#
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FDA Review#
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