The following data is part of a premarket notification filed by Stryker Sustainability Solutions, Inc. with the FDA for Reprocessed Ultrasound Intracardiac Echo Catheter.
| Device ID | K121913 |
| 510k Number | K121913 |
| Device Name: | REPROCESSED ULTRASOUND INTRACARDIAC ECHO CATHETER |
| Classification | Reprocessed Intravascular Ultrasound Catheter |
| Applicant | STRYKER SUSTAINABILITY SOLUTIONS, INC. 10232 S. 51st St. Phoenix, AZ 85044 |
| Contact | Moira Barton-varty |
| Correspondent | Moira Barton-varty STRYKER SUSTAINABILITY SOLUTIONS, INC. 10232 S. 51st St. Phoenix, AZ 85044 |
| Product Code | OWQ |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-02 |
| Decision Date | 2012-12-20 |
| Summary: | summary |