The following data is part of a premarket notification filed by Stryker Neurovascular with the FDA for Transgate Guide Catheter.
| Device ID | K132542 |
| 510k Number | K132542 |
| Device Name: | TRANSGATE GUIDE CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | STRYKER NEUROVASCULAR 47900 BAYSIDE PARKWAY Fremont, CA 94538 |
| Contact | Anjali Atal-gupta |
| Correspondent | Anjali Atal-gupta STRYKER NEUROVASCULAR 47900 BAYSIDE PARKWAY Fremont, CA 94538 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-13 |
| Decision Date | 2013-11-15 |
| Summary: | summary |