The following data is part of a premarket notification filed by Innovative Health, Llc. with the FDA for Reprocessed Carto Vizigo Bi-directional Guiding Sheath.
| Device ID | K212165 |
| 510k Number | K212165 |
| Device Name: | Reprocessed Carto Vizigo Bi-Directional Guiding Sheath |
| Classification | Reprocessed Catheter Introducer |
| Applicant | Innovative Health, LLC. 1435 North Hayden Road, Suite 100 Scottsdale, AZ 85257 |
| Contact | Rick Ferreira |
| Correspondent | Amanda Babcock 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 | 2021-07-12 |
| Decision Date | 2022-03-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841898131561 | K212165 | 000 |
| 10841898131554 | K212165 | 000 |
| 10841898131547 | K212165 | 000 |