The following data is part of a premarket notification filed by Veran Medical Technologies, Inc. with the FDA for Ig4 Endobronchial, Model Sys-0200, Navigation Guidewire (accessory To Ig4 Endobronchial), Model Ins-0300.
| Device ID | K091934 |
| 510k Number | K091934 |
| Device Name: | IG4 ENDOBRONCHIAL, MODEL SYS-0200, NAVIGATION GUIDEWIRE (ACCESSORY TO IG4 ENDOBRONCHIAL), MODEL INS-0300 |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | VERAN MEDICAL TECHNOLOGIES, INC. 5743 WEST PARK AVE St. Louis, MO 63110 |
| Contact | Scott Wrightstone |
| Correspondent | Scott Wrightstone VERAN MEDICAL TECHNOLOGIES, INC. 5743 WEST PARK AVE St. Louis, MO 63110 |
| Product Code | JAK |
| Subsequent Product Code | KTI |
| Subsequent Product Code | LLZ |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-30 |
| Decision Date | 2009-12-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10815686020443 | K091934 | 000 |
| 10815686020436 | K091934 | 000 |