The following data is part of a premarket notification filed by Micro Therapeutics, Inc. with the FDA for 14 Wire Standard, 14 Wire Ls.
| Device ID | K113454 |
| 510k Number | K113454 |
| Device Name: | 14 WIRE STANDARD, 14 WIRE LS |
| Classification | Wire, Guide, Catheter |
| Applicant | MICRO THERAPEUTICS, INC. 9775 TOLEDO WAY Irvine, CA 92618 |
| Contact | Gregory J Geissinger |
| Correspondent | Gregory J Geissinger MICRO THERAPEUTICS, INC. 9775 TOLEDO WAY Irvine, CA 92618 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-21 |
| Decision Date | 2012-02-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847536004764 | K113454 | 000 |
| 00763000338275 | K113454 | 000 |