The following data is part of a premarket notification filed by Innovative Health, Llc. with the FDA for Reprocessed Nrg Transseptal Needle.
| Device ID | K200060 |
| 510k Number | K200060 |
| Device Name: | Reprocessed NRG Transseptal Needle |
| Classification | Septostomy Catheter, Reprocessed |
| Applicant | Innovative Health, LLC. 1435 North Hayden Road, Suite 100 Scottsdale, AZ 85257 |
| Contact | Rick Ferreira |
| Correspondent | Christina Fleming Innovative Health, LLC. 1435 North Hayden Road, Suite 100 Scottsdale, AZ 85257 |
| Product Code | QLZ |
| CFR Regulation Number | 870.5175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-13 |
| Decision Date | 2020-07-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841898130854 | K200060 | 000 |
| 10841898130830 | K200060 | 000 |
| 10841898130823 | K200060 | 000 |
| 10841898130809 | K200060 | 000 |