The following data is part of a premarket notification filed by Micro Therapeutics, Inc. with the FDA for Micro Therapeutics Sidehole Infusion Wire.
| Device ID | K954020 |
| 510k Number | K954020 |
| Device Name: | MICRO THERAPEUTICS SIDEHOLE INFUSION WIRE |
| Classification | Catheter, Continuous Flush |
| Applicant | MICRO THERAPEUTICS, INC. 27412-B LAGUNA HILLS DR. Aliso Viejo, CA 92656 |
| Contact | Linda D'abate |
| Correspondent | Linda D'abate MICRO THERAPEUTICS, INC. 27412-B LAGUNA HILLS DR. Aliso Viejo, CA 92656 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-28 |
| Decision Date | 1996-01-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00836462000513 | K954020 | 000 |
| 00836462000506 | K954020 | 000 |
| 00836462000490 | K954020 | 000 |
| 00836462000476 | K954020 | 000 |
| 00836462000469 | K954020 | 000 |
| 00836462000452 | K954020 | 000 |