The following data is part of a premarket notification filed by Micro Therapeutics, Inc. with the FDA for Echelon Micro Catheter, Models 105-5092-150sa, 145-5092-150sa And 190-5092-150sa And Syringe Adapter Accessory.
| Device ID | K090870 |
| 510k Number | K090870 |
| Device Name: | ECHELON MICRO CATHETER, MODELS 105-5092-150SA, 145-5092-150SA AND 190-5092-150SA AND SYRINGE ADAPTER ACCESSORY |
| Classification | Catheter, Continuous Flush |
| Applicant | MICRO THERAPEUTICS, INC. 9775 TOLEDO WAY Irvine, CA 92618 |
| Contact | Tom Daughters |
| Correspondent | Tom Daughters MICRO THERAPEUTICS, INC. 9775 TOLEDO WAY Irvine, CA 92618 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-30 |
| Decision Date | 2009-05-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00836462006140 | K090870 | 000 |