The following data is part of a premarket notification filed by Boston Scientific Scimed, Inc. with the FDA for Laguna Softip Diagnostic Catheters.
| Device ID | K961499 |
| 510k Number | K961499 |
| Device Name: | LAGUNA SOFTIP DIAGNOSTIC CATHETERS |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | BOSTON SCIENTIFIC SCIMED, INC. 5905 NATHAN LN. Minneapolis, MN 55442 |
| Contact | Maria Brittle |
| Correspondent | Maria Brittle BOSTON SCIENTIFIC SCIMED, INC. 5905 NATHAN LN. Minneapolis, MN 55442 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-18 |
| Decision Date | 1996-10-17 |
| Summary: | summary |