The following data is part of a premarket notification filed by Boston Scientific Scimed, Inc. with the FDA for Smash Percutaneous Transluminal Angioplasty (pta) Cardiovascular Devices Panel.
| Device ID | K972512 |
| 510k Number | K972512 |
| Device Name: | SMASH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CARDIOVASCULAR DEVICES PANEL |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | BOSTON SCIENTIFIC SCIMED, INC. 5905 NATHAN LN. Minneapolis, MN 55442 |
| Contact | Ron Bennett |
| Correspondent | Ron Bennett 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 | 1997-07-07 |
| Decision Date | 1998-02-12 |
| Summary: | summary |