The following data is part of a premarket notification filed by Boston Scientific, Target with the FDA for Atlantis Sr Plus Coronary Imaging Catheter, Model 35975.
Device ID | K010707 |
510k Number | K010707 |
Device Name: | ATLANTIS SR PLUS CORONARY IMAGING CATHETER, MODEL 35975 |
Classification | Catheter, Intravascular, Diagnostic |
Applicant | BOSTON SCIENTIFIC, TARGET 47900 BAYSIDE PKWY. Fremont, CA 94538 |
Contact | Irene Jaworski |
Correspondent | Irene Jaworski BOSTON SCIENTIFIC, TARGET 47900 BAYSIDE PKWY. Fremont, CA 94538 |
Product Code | DQO |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-03-09 |
Decision Date | 2001-03-29 |