The following data is part of a premarket notification filed by Microvention, Inc. with the FDA for Headway 17 Advanced Microcatheter.
| Device ID | K101542 |
| 510k Number | K101542 |
| Device Name: | HEADWAY 17 ADVANCED MICROCATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | MICROVENTION, INC. 1311 VALENCIA AVE Tustin, CA 92780 |
| Contact | Naomi Gong |
| 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 | 2010-06-03 |
| Decision Date | 2010-08-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810170015519 | K101542 | 000 |
| 00810170015502 | K101542 | 000 |
| 00810170015496 | K101542 | 000 |
| 00810170015489 | K101542 | 000 |
| 00810170013751 | K101542 | 000 |