The following data is part of a premarket notification filed by Micro Therapeutics, Inc. with the FDA for Silverstreak Hydrophilic Guidewire.
| Device ID | K982543 |
| 510k Number | K982543 |
| Device Name: | SILVERSTREAK HYDROPHILIC GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | MICRO THERAPEUTICS, INC. 1062-F CALLE NEGOCIO San Clemente, CA 92673 |
| Contact | Tom Daughters |
| Correspondent | Tom Daughters MICRO THERAPEUTICS, INC. 1062-F CALLE NEGOCIO San Clemente, CA 92673 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-21 |
| Decision Date | 1998-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847536004382 | K982543 | 000 |
| 00836462003019 | K982543 | 000 |