The following data is part of a premarket notification filed by Solo-dex, Inc. with the FDA for Solo-dex Fascile Continuous Peripheral Nerve Block Catheter And Needle Kit.
| Device ID | K151072 |
| 510k Number | K151072 |
| Device Name: | Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter And Needle Kit |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | Solo-Dex, Inc. 3 Moonlight Isle Ladera Ranch, CA 92694 |
| Contact | Siddarth Desai |
| Correspondent | Albert Rego ALBERT REGO, PH.D. 27001 LA PAZ ROAD, SUITE 312 Mission Viejo, CA 92691 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-21 |
| Decision Date | 2016-01-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B3723000303025 | K151072 | 000 |
| 10850001913048 | K151072 | 000 |
| 10850001913109 | K151072 | 000 |
| 10850001913154 | K151072 | 000 |
| 10850001913277 | K151072 | 000 |
| 08500019130009 | K151072 | 000 |
| B3723000301015 | K151072 | 000 |
| B3723000301025 | K151072 | 000 |
| B3723000303015 | K151072 | 000 |
| 00850001913355 | K151072 | 000 |