The following data is part of a premarket notification filed by Stryker Sustainability Solutions with the FDA for Reprocessed Viewflex Xtra Ice Catheter.
| Device ID | K182238 |
| 510k Number | K182238 |
| Device Name: | Reprocessed ViewFlex Xtra ICE Catheter |
| Classification | Reprocessed Intravascular Ultrasound Catheter |
| Applicant | Stryker Sustainability Solutions 1810 West Drake Drive Tempe, AZ 85283 |
| Contact | Ramona Kulik |
| Correspondent | Ramona Kulik Stryker Sustainability Solutions 1810 West Drake Drive Tempe, AZ 85283 |
| Product Code | OWQ |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-20 |
| Decision Date | 2019-05-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327376067 | K182238 | 000 |