The following data is part of a premarket notification filed by Boston Scientific Scimed, Inc. with the FDA for Schneider Pink Power Softip Guidnig Catheter.
| Device ID | K943622 |
| 510k Number | K943622 |
| Device Name: | SCHNEIDER PINK POWER SOFTIP GUIDNIG CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | BOSTON SCIENTIFIC SCIMED, INC. 5905 NATHAN LN. Minneapolis, MN 55442 |
| Contact | Lars Bansberg, Ph.d. |
| Correspondent | Lars Bansberg, Ph.d. BOSTON SCIENTIFIC SCIMED, INC. 5905 NATHAN LN. Minneapolis, MN 55442 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-27 |
| Decision Date | 1994-11-30 |