The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Excelsior 1018 And Sl-10 Microcatheters.
| Device ID | K042568 |
| 510k Number | K042568 |
| Device Name: | EXCELSIOR 1018 AND SL-10 MICROCATHETERS |
| Classification | Catheter, Percutaneous |
| Applicant | BOSTON SCIENTIFIC CORP. 47900 BAYSIDE PARKWAY Fremont, CA 94538 -6515 |
| Contact | Victor Ham |
| Correspondent | Victor Ham BOSTON SCIENTIFIC CORP. 47900 BAYSIDE PARKWAY Fremont, CA 94538 -6515 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-21 |
| Decision Date | 2004-10-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327064766 | K042568 | 000 |
| 04546540688149 | K042568 | 000 |
| 04546540688156 | K042568 | 000 |
| 04546540688163 | K042568 | 000 |
| 04546540688170 | K042568 | 000 |
| 04546540688224 | K042568 | 000 |
| 04546540688231 | K042568 | 000 |
| 04546540688248 | K042568 | 000 |
| 04546540688255 | K042568 | 000 |
| 04546540688262 | K042568 | 000 |
| 07613327064728 | K042568 | 000 |
| 07613327064735 | K042568 | 000 |
| 07613327064742 | K042568 | 000 |
| 07613327064759 | K042568 | 000 |
| 04546540688132 | K042568 | 000 |