The following data is part of a premarket notification filed by Innovative Health, Llc. with the FDA for Reprocessed Orbiter St Steerable Diagnostic Ep Catheter.
| Device ID | K161393 |
| 510k Number | K161393 |
| Device Name: | Reprocessed Orbiter ST Steerable Diagnostic EP Catheter |
| Classification | Catheter, Recording, Electrode, Reprocessed |
| Applicant | Innovative Health, LLC. 1435 North Hayden Road, Suite 100 Scottsdale, AZ 85257 |
| Contact | Rafal Chudzik |
| Correspondent | Rafal Chudzik 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 | 2016-05-19 |
| Decision Date | 2016-10-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841898122026 | K161393 | 000 |
| 10841898121975 | K161393 | 000 |
| 10841898122002 | K161393 | 000 |
| 10841898122019 | K161393 | 000 |
| 10841898122040 | K161393 | 000 |
| 10841898122064 | K161393 | 000 |
| 10841898122071 | K161393 | 000 |
| 10841898121982 | K161393 | 000 |
| 10841898121999 | K161393 | 000 |
| 10841898122033 | K161393 | 000 |
| 10841898122057 | K161393 | 000 |
| 10841898121968 | K161393 | 000 |