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 |