The following data is part of a premarket notification filed by Veran Medical Technologies, Inc. with the FDA for Spin Drive Always-on Tip Tracked Steerable Catheter Always-on Tip Tracked Sheath Always-on Tip Tracked Aspiration Needle.
| Device ID | K122106 |
| 510k Number | K122106 |
| Device Name: | SPIN DRIVE ALWAYS-ON TIP TRACKED STEERABLE CATHETER ALWAYS-ON TIP TRACKED SHEATH ALWAYS-ON TIP TRACKED ASPIRATION NEEDLE |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | VERAN MEDICAL TECHNOLOGIES, INC. 1908 Innerbelt Business Center Dr Saint Louis, MO 63114 |
| Contact | Scott Wrightstone |
| Correspondent | Scott Wrightstone VERAN MEDICAL TECHNOLOGIES, INC. 1908 Innerbelt Business Center Dr Saint Louis, MO 63114 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-17 |
| Decision Date | 2012-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815686021108 | K122106 | 000 |
| 10815686020511 | K122106 | 000 |
| 10815686020474 | K122106 | 000 |
| 10815686020405 | K122106 | 000 |
| 00815686020392 | K122106 | 000 |
| 00815686020118 | K122106 | 000 |
| 00815686020101 | K122106 | 000 |
| 00815686020095 | K122106 | 000 |
| 00815686020088 | K122106 | 000 |
| 00815686020071 | K122106 | 000 |
| 00815686020064 | K122106 | 000 |
| 00815686020057 | K122106 | 000 |
| 10815686020535 | K122106 | 000 |
| 00815686020552 | K122106 | 000 |
| 00815686020576 | K122106 | 000 |
| 00815686021092 | K122106 | 000 |
| 00815686021085 | K122106 | 000 |
| 00815686021078 | K122106 | 000 |
| 00815686020736 | K122106 | 000 |
| 00815686020729 | K122106 | 000 |
| 00815686020712 | K122106 | 000 |
| 00815686020651 | K122106 | 000 |
| 00815686020644 | K122106 | 000 |
| 00815686020637 | K122106 | 000 |
| 00815686020613 | K122106 | 000 |
| 00815686020590 | K122106 | 000 |
| 00815686020033 | K122106 | 000 |