510(k) K834565
- Device
- ENDOBRONCHIAL TWIN LUMEN TUBE
- Applicant
- PORTEX, INC.
- 510(k) number
- K834565
- Product code
- BTS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-01-17
- Date received
- 1983-12-28
- Regulation
- 868.5720
- Classification name
- Tube, Bronchial (w/wo Connector)
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 1820334
- 3011137372
- 8020889
- 3002807561
- 3003898360
- 2936999
- 3002807314
- 3014656749
- 3018094310
- 3004365956
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| K951091 | RUSCH ENDOBRONCHIAL TUBE SETS | Rusch Intl. | 1995-06-08 |
| K902116 | MODIFIED ENDOBRONCHIAL TUBE | Concord/Portex | 1990-08-03 |
| 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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