The following data is part of a premarket notification filed by Boston Scientific, Target with the FDA for Excelsior 1018 Microcatheter.
| Device ID | K994155 |
| 510k Number | K994155 |
| Device Name: | EXCELSIOR 1018 MICROCATHETER |
| Classification | Catheter, Continuous Flush |
| Applicant | BOSTON SCIENTIFIC, TARGET 47900 BAYSIDE PKWY. Fremont, CA 94538 |
| Contact | Roxanne K Baxter |
| Correspondent | Roxanne K Baxter BOSTON SCIENTIFIC, TARGET 47900 BAYSIDE PKWY. Fremont, CA 94538 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-09 |
| Decision Date | 2000-08-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04546540688125 | K994155 | 000 |
| 04546540688118 | K994155 | 000 |