The following data is part of a premarket notification filed by Stryker Sustainability Solutions with the FDA for Reprocessed Cs Diagnostic Electrophysiology Catheter.
| Device ID | K181056 |
| 510k Number | K181056 |
| Device Name: | Reprocessed CS Diagnostic Electrophysiology Catheter |
| Classification | Catheter, Recording, Electrode, Reprocessed |
| Applicant | Stryker Sustainability Solutions 1810 W. Drake Drive Tempe, AZ 85283 |
| Contact | Mia Mccorkel |
| Correspondent | Mia Mccorkel Stryker Sustainability Solutions 1810 W. Drake Drive Tempe, AZ 85283 |
| Product Code | NLH |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-20 |
| Decision Date | 2019-01-24 |
| Summary: | summary |