The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Snap-on Torquer.
Device ID | K862409 |
510k Number | K862409 |
Device Name: | SNAP-ON TORQUER |
Classification | Wire, Guide, Catheter |
Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1395 CHARLESTON RD. Mountain View, CA 94043 |
Contact | Marianna Faist |
Correspondent | Marianna Faist ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1395 CHARLESTON RD. Mountain View, CA 94043 |
Product Code | DQX |
CFR Regulation Number | 870.1330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-06-25 |
Decision Date | 1986-07-11 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SNAP-ON TORQUER 73616436 1478522 Dead/Cancelled |
ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1986-08-25 |