The following data is part of a premarket notification filed by Stryker Neurovascular with the FDA for Transform Occlusion Balloon Catheter (compliant And Super Compliant.
| Device ID | K122576 |
| 510k Number | K122576 |
| Device Name: | TRANSFORM OCCLUSION BALLOON CATHETER (COMPLIANT AND SUPER COMPLIANT |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | STRYKER NEUROVASCULAR 47900 BAYSIDE PARKWAY Fremont, CA 94538 |
| Contact | James Leathley |
| Correspondent | James Leathley STRYKER NEUROVASCULAR 47900 BAYSIDE PARKWAY Fremont, CA 94538 |
| Product Code | MJN |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-23 |
| Decision Date | 2013-01-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327004717 | K122576 | 000 |
| 07613327004427 | K122576 | 000 |
| 07613327004434 | K122576 | 000 |
| 07613327004441 | K122576 | 000 |
| 07613327004458 | K122576 | 000 |
| 07613327004465 | K122576 | 000 |
| 07613327004472 | K122576 | 000 |
| 07613327004489 | K122576 | 000 |
| 07613327004496 | K122576 | 000 |
| 07613327004502 | K122576 | 000 |
| 07613327004519 | K122576 | 000 |
| 07613327004526 | K122576 | 000 |
| 07613327004687 | K122576 | 000 |
| 07613327004694 | K122576 | 000 |
| 07613327004700 | K122576 | 000 |
| 07613327004410 | K122576 | 000 |