The following data is part of a premarket notification filed by Vbm Medizintechnik Gmbh with the FDA for Transtracheal Catheter (acc. Ravussin)..
| Device ID | K955461 |
| 510k Number | K955461 |
| Device Name: | TRANSTRACHEAL CATHETER (ACC. RAVUSSIN). |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | VBM MEDIZINTECHNIK GMBH 6072 SOUTH 2550 WEST Roy, UT 84067 -3211 |
| Contact | R. Douglas Jacob |
| Correspondent | R. Douglas Jacob VBM MEDIZINTECHNIK GMBH 6072 SOUTH 2550 WEST Roy, UT 84067 -3211 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-29 |
| Decision Date | 1997-03-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04250105605136 | K955461 | 000 |
| 04250105605129 | K955461 | 000 |
| 04250105605112 | K955461 | 000 |
| 14250105605102 | K955461 | 000 |
| 14250105605096 | K955461 | 000 |
| 14250105605089 | K955461 | 000 |
| M996ACU106010 | K955461 | 000 |