The following data is part of a premarket notification filed by Medtronic Vascular, Inc.(formerly Ev3 Inc.) with the FDA for Trailblazer Angled Support Catheter.
| Device ID | K162384 |
| 510k Number | K162384 |
| Device Name: | TrailBlazer Angled Support Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | Medtronic Vascular, Inc.(formerly Ev3 Inc.) 3033 Campus Dr Plymouth, MN 55441 |
| Contact | David Robertson |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2016-08-25 |
| Decision Date | 2016-09-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20643169694945 | K162384 | 000 |
| 20763000004815 | K162384 | 000 |
| 20763000004822 | K162384 | 000 |
| 20763000004839 | K162384 | 000 |
| 20763000004846 | K162384 | 000 |
| 20763000004853 | K162384 | 000 |
| 20763000004860 | K162384 | 000 |
| 20763000004877 | K162384 | 000 |
| 20763000004884 | K162384 | 000 |
| 20763000004808 | K162384 | 000 |
| 20763000770383 | K162384 | 000 |
| 20763000770307 | K162384 | 000 |
| 20763000770314 | K162384 | 000 |
| 20763000770321 | K162384 | 000 |
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| 20763000770345 | K162384 | 000 |
| 20763000770352 | K162384 | 000 |
| 20763000770369 | K162384 | 000 |
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| 20763000004891 | K162384 | 000 |
| 20763000104645 | K162384 | 000 |
| 20643169694860 | K162384 | 000 |
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| 20643169694884 | K162384 | 000 |
| 20643169694891 | K162384 | 000 |
| 20643169694907 | K162384 | 000 |
| 20643169694914 | K162384 | 000 |
| 20643169694921 | K162384 | 000 |
| 20643169694938 | K162384 | 000 |
| 20643169694853 | K162384 | 000 |
| 20763000104737 | K162384 | 000 |
| 20763000104652 | K162384 | 000 |
| 20763000104669 | K162384 | 000 |
| 20763000104676 | K162384 | 000 |
| 20763000104683 | K162384 | 000 |
| 20763000104690 | K162384 | 000 |
| 20763000104706 | K162384 | 000 |
| 20763000104713 | K162384 | 000 |
| 20763000104720 | K162384 | 000 |
| 20763000770291 | K162384 | 000 |