The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Rusch Endobronchial Tubes.
| Device ID | K141888 |
| 510k Number | K141888 |
| Device Name: | RUSCH ENDOBRONCHIAL TUBES |
| Classification | Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) |
| Applicant | Teleflex Medical, Inc. 2917 WECK DR. Research Triangle Park, NC 27709 |
| Contact | Lori Pfohl |
| Correspondent | Lori Pfohl Teleflex Medical, Inc. 2917 WECK DR. Research Triangle Park, NC 27709 |
| Product Code | CBI |
| CFR Regulation Number | 868.5740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-14 |
| Decision Date | 2015-04-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 44026704344398 | K141888 | 000 |
| 24026704344288 | K141888 | 000 |
| 44026704344275 | K141888 | 000 |
| 24026704344264 | K141888 | 000 |
| 44026704344251 | K141888 | 000 |
| 24026704344240 | K141888 | 000 |
| 24026704344233 | K141888 | 000 |
| 24026704344226 | K141888 | 000 |
| 44026704344213 | K141888 | 000 |
| 44026704344299 | K141888 | 000 |
| 24026704344301 | K141888 | 000 |
| 24026704344387 | K141888 | 000 |
| 44026704344374 | K141888 | 000 |
| 24026704344363 | K141888 | 000 |
| 24026704344356 | K141888 | 000 |
| 44026704344343 | K141888 | 000 |
| 24026704344332 | K141888 | 000 |
| 24026704344325 | K141888 | 000 |
| 44026704344312 | K141888 | 000 |
| 44026704344206 | K141888 | 000 |