The following data is part of a premarket notification filed by Boston Scientific, Target with the FDA for Excelsior Sl-10 Microcatheter, Models 168581, 168381, 168181, 168189.
| Device ID | K013789 |
| 510k Number | K013789 |
| Device Name: | EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189 |
| Classification | Catheter, Percutaneous |
| Applicant | BOSTON SCIENTIFIC, TARGET 47900 BAYSIDE PKWY. Fremont, CA 94538 |
| Contact | George J Prendergast |
| Correspondent | George J Prendergast BOSTON SCIENTIFIC, TARGET 47900 BAYSIDE PKWY. Fremont, CA 94538 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-14 |
| Decision Date | 2001-12-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327124262 | K013789 | 000 |
| 07613327124255 | K013789 | 000 |
| 04546540688217 | K013789 | 000 |
| 04546540688200 | K013789 | 000 |