The following data is part of a premarket notification filed by Innovative Health, Llc. with the FDA for Reprocessed Torqr Diagnostic Ep Catheter.
| Device ID | K181618 |
| 510k Number | K181618 |
| Device Name: | Reprocessed Torqr Diagnostic EP Catheter |
| Classification | Catheter, Recording, Electrode, 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 | NLH |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-19 |
| Decision Date | 2018-10-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841898128691 | K181618 | 000 |
| 10841898128639 | K181618 | 000 |
| 10841898128660 | K181618 | 000 |
| 10841898128653 | K181618 | 000 |
| 10841898128646 | K181618 | 000 |
| 10841898128622 | K181618 | 000 |
| 10841898128615 | K181618 | 000 |
| 10841898128608 | K181618 | 000 |
| 10841898128578 | K181618 | 000 |