The following data is part of a premarket notification filed by Innovative Health, Llc. with the FDA for Reprocessed Brk Transseptal Needle.
| Device ID | K192998 |
| 510k Number | K192998 |
| Device Name: | Reprocessed BRK Transseptal Needle |
| Classification | Trocar, Reprocessed |
| Applicant | Innovative Health, LLC. 1435 North Hayden Road, Suite 100 Scottsdale, AZ 85257 |
| Contact | Amanda Babcock |
| Correspondent | Amanda Babcock Innovative Health, LLC. 1435 North Hayden Road, Suite 100 Scottsdale, AZ 85257 |
| Product Code | NMK |
| CFR Regulation Number | 870.1390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-28 |
| Decision Date | 2020-07-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841898129865 | K192998 | 000 |
| 10841898129766 | K192998 | 000 |
| 10841898129773 | K192998 | 000 |
| 10841898129780 | K192998 | 000 |
| 10841898129797 | K192998 | 000 |
| 10841898129803 | K192998 | 000 |
| 10841898129810 | K192998 | 000 |
| 10841898129827 | K192998 | 000 |
| 10841898129834 | K192998 | 000 |
| 10841898129841 | K192998 | 000 |
| 10841898129858 | K192998 | 000 |
| 10841898129759 | K192998 | 000 |