The following data is part of a premarket notification filed by Microvention, Inc. with the FDA for Headway 17 Microcatheter.
| Device ID | K083343 |
| 510k Number | K083343 |
| Device Name: | HEADWAY 17 MICROCATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | MICROVENTION, INC. 75 COLUMBIA SUITE A Aliso Viejo, CA 92656 -1408 |
| 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 | 2008-11-13 |
| Decision Date | 2008-12-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810170013744 | K083343 | 000 |