The following data is part of a premarket notification filed by Stryker Neurovascular with the FDA for Excelsior Xt-27 Microcatheter.
| Device ID | K113778 |
| 510k Number | K113778 |
| Device Name: | EXCELSIOR XT-27 MICROCATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | STRYKER NEUROVASCULAR 47900 BAYSIDE PARKWAY Fremont, CA 94538 |
| Contact | Yoko Y Enrile |
| Correspondent | J.a. N Van Vugt DEKRA CERTIFICATION B.V. UTRECHTSEWEG 310 Arnhem, NL Nl-6812 Ar |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-12-22 |
| Decision Date | 2012-04-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04546540698162 | K113778 | 000 |
| 04546540698155 | K113778 | 000 |
| 04546540698148 | K113778 | 000 |
| 04546540698131 | K113778 | 000 |
| 04546540698124 | K113778 | 000 |
| 04546540698117 | K113778 | 000 |
| 04546540698100 | K113778 | 000 |
| 04546540698094 | K113778 | 000 |