The following data is part of a premarket notification filed by Ev3 Inc with the FDA for Trailblazer Support Catheter.
| Device ID | K092299 |
| 510k Number | K092299 |
| Device Name: | TRAILBLAZER SUPPORT CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | EV3 INC 1394 25TH STREET NW Buffalo, MN 55113 -2920 |
| Contact | David Robertson |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-07-29 |
| Decision Date | 2009-08-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821684058077 | K092299 | 000 |
| 20643169996162 | K092299 | 000 |
| 20643169996155 | K092299 | 000 |
| 20643169996148 | K092299 | 000 |
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| 20643169996094 | K092299 | 000 |
| 20763000762821 | K092299 | 000 |
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| 20763000104744 | K092299 | 000 |
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| 00821684058046 | K092299 | 000 |
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| 00821684058022 | K092299 | 000 |
| 00821684058015 | K092299 | 000 |
| 00821684058008 | K092299 | 000 |
| 00821684057995 | K092299 | 000 |
| 00821684057988 | K092299 | 000 |
| 00821684057971 | K092299 | 000 |
| 00821684073964 | K092299 | 000 |
| 20763000104829 | K092299 | 000 |
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| 20763000104799 | K092299 | 000 |
| 20763000104782 | K092299 | 000 |
| 20763000104775 | K092299 | 000 |
| 20763000104768 | K092299 | 000 |
| 20763000762746 | K092299 | 000 |