The following data is part of a premarket notification filed by Boston Scientific Scimed, Inc. with the FDA for Schneider Total Cross And Match 35 Percutanewous Transluminal Angioplasty Catheters.
| Device ID | K942154 |
| 510k Number | K942154 |
| Device Name: | SCHNEIDER TOTAL CROSS AND MATCH 35 PERCUTANEWOUS TRANSLUMINAL ANGIOPLASTY CATHETERS |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | BOSTON SCIENTIFIC SCIMED, INC. 5905 NATHAN LN. Minneapolis, MN 55442 |
| Contact | Tracy Malm |
| Correspondent | Tracy Malm BOSTON SCIENTIFIC SCIMED, INC. 5905 NATHAN LN. Minneapolis, MN 55442 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-15 |
| Decision Date | 1994-08-18 |