The following data is part of a premarket notification filed by Innovative Health, Llc. with the FDA for Reprocessed Agilis Nxt Steerable Introducer.
| Device ID | K170311 |
| 510k Number | K170311 |
| Device Name: | Reprocessed Agilis NxT Steerable Introducer |
| Classification | Reprocessed Catheter Introducer |
| Applicant | Innovative Health, LLC. 1435 North Hayden Road, Suite 100 Scottsdale, AZ 85257 |
| Contact | Amy Stoklas-oakes |
| Correspondent | Amy Stoklas-oakes Innovative Health, LLC. 1435 North Hayden Road, Suite 100 Scottsdale, AZ 85257 |
| Product Code | PNE |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-01 |
| Decision Date | 2017-06-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841898130212 | K170311 | 000 |
| 10841898120251 | K170311 | 000 |
| 10841898120268 | K170311 | 000 |
| 10841898120275 | K170311 | 000 |
| 10841898120282 | K170311 | 000 |
| 10841898128172 | K170311 | 000 |
| 10841898128196 | K170311 | 000 |
| 10841898130144 | K170311 | 000 |
| 10841898130151 | K170311 | 000 |
| 10841898130168 | K170311 | 000 |
| 10841898130175 | K170311 | 000 |
| 10841898130182 | K170311 | 000 |
| 10841898130199 | K170311 | 000 |
| 10841898130205 | K170311 | 000 |
| 10841898120244 | K170311 | 000 |