The following data is part of a premarket notification filed by Boston Scientific Scimed, Inc. with the FDA for Modification To Scimed 6f Impulse Angiographic Cathaters.
| Device ID | K000956 |
| 510k Number | K000956 |
| Device Name: | MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | BOSTON SCIENTIFIC SCIMED, INC. ONE SCIMED PLACE Maple Grove, MN 55311 |
| Contact | Melanie Raska |
| Correspondent | Melanie Raska BOSTON SCIENTIFIC SCIMED, INC. ONE SCIMED PLACE Maple Grove, MN 55311 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-24 |
| Decision Date | 2000-04-21 |