The following data is part of a premarket notification filed by Boston Scientific Scimed, Inc. with the FDA for Scimed Impulse Angiographic Catheters.
| Device ID | K992123 |
| 510k Number | K992123 |
| Device Name: | SCIMED IMPULSE ANGIOGRAPHIC CATHETERS |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | BOSTON SCIENTIFIC SCIMED, INC. ONE SCIEMD PLACE Maple Grove, MN 55311 -1566 |
| Contact | Melanie Raska |
| Correspondent | Melanie Raska BOSTON SCIENTIFIC SCIMED, INC. ONE SCIEMD PLACE Maple Grove, MN 55311 -1566 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-23 |
| Decision Date | 1999-08-23 |
| Summary: | summary |