The following data is part of a premarket notification filed by Micro Therapeutics, Inc. with the FDA for Silverspeed Hydrophilic Guidewire (0.014 Diameter, 145cm Length, Support) Silverspeed Hydrophilic Guidewire (0.014 D.
| Device ID | K001454 |
| 510k Number | K001454 |
| Device Name: | SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 DIAMETER, 145CM LENGTH, SUPPORT) SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 D |
| Classification | Wire, Guide, Catheter |
| Applicant | MICRO THERAPEUTICS, INC. 2 GOODYEAR Irvine, CA 92618 |
| Contact | Maribelle Aguinaldo |
| Correspondent | Maribelle Aguinaldo MICRO THERAPEUTICS, INC. 2 GOODYEAR Irvine, CA 92618 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-09 |
| Decision Date | 2000-06-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847536006355 | K001454 | 000 |
| 00847536004726 | K001454 | 000 |
| 00836462003224 | K001454 | 000 |
| 00836462003170 | K001454 | 000 |
| 00763000518929 | K001454 | 000 |