The following data is part of a premarket notification filed by Stryker Sustainability Solutions with the FDA for Reprocessed 2515 Nav Variable Electrophysiology Catheter.
| Device ID | K112292 |
| 510k Number | K112292 |
| Device Name: | REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER |
| Classification | Catheter, Recording, Electrode, Reprocessed |
| Applicant | STRYKER SUSTAINABILITY SOLUTIONS 1810 W. Drake Dr. Tempe, AZ 85283 |
| Contact | Ramona Kulik |
| Correspondent | Ramona Kulik STRYKER SUSTAINABILITY SOLUTIONS 1810 W. Drake Dr. 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 | 2011-08-10 |
| Decision Date | 2011-10-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885825011697 | K112292 | 000 |
| 07613327361940 | K112292 | 000 |
| 07613327361957 | K112292 | 000 |
| 07613327361964 | K112292 | 000 |
| 07613327361971 | K112292 | 000 |
| 07613327361988 | K112292 | 000 |
| 07613327361995 | K112292 | 000 |
| 00885825011505 | K112292 | 000 |
| 00885825011680 | K112292 | 000 |
| 00885825011512 | K112292 | 000 |