The following data is part of a premarket notification filed by Stryker Neurovascular with the FDA for Excelsior Xt-17 Microcatheter, Excelsior Xt-17 Flex Microcatheter, Excelsior Xt-17 Pre-shaped Microcatheter, Excelsior Xt-17 Flex Pre-shaped Microcatheter.
| Device ID | K142565 |
| 510k Number | K142565 |
| Device Name: | Excelsior XT-17 Microcatheter, Excelsior XT-17 Flex Microcatheter, Excelsior XT-17 Pre-Shaped Microcatheter, Excelsior XT-17 Flex Pre-Shaped Microcatheter |
| Classification | Catheter, Percutaneous |
| Applicant | Stryker Neurovascular 47900 Bayside Parkway Fremont, CA 94538 |
| Contact | Yoko Enrile |
| Correspondent | Yoko Enrile Stryker Neurovascular 47900 Bayside Parkway Fremont, CA 94538 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-12 |
| Decision Date | 2014-11-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613252714934 | K142565 | 000 |
| 07613252714798 | K142565 | 000 |
| 07613252714804 | K142565 | 000 |
| 07613252714811 | K142565 | 000 |
| 07613252714828 | K142565 | 000 |
| 07613252714835 | K142565 | 000 |
| 07613252714842 | K142565 | 000 |
| 07613252714859 | K142565 | 000 |
| 07613252714866 | K142565 | 000 |
| 07613252714873 | K142565 | 000 |
| 07613252714880 | K142565 | 000 |
| 07613252714897 | K142565 | 000 |
| 07613252714903 | K142565 | 000 |
| 07613252714910 | K142565 | 000 |
| 07613252714927 | K142565 | 000 |
| 07613252714781 | K142565 | 000 |