The following data is part of a premarket notification filed by Biosense Webster, Inc. with the FDA for Soundstar 3d Ultrasound Catheter, Model M-5723-05.
Device ID | K070242 |
510k Number | K070242 |
Device Name: | SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-05 |
Classification | Catheter, Ultrasound, Intravascular |
Applicant | BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. Diamond Bar, CA 91765 |
Contact | Neelu Medhekar |
Correspondent | Neelu Medhekar BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. Diamond Bar, CA 91765 |
Product Code | OBJ |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-02-09 |
Decision Date | 2007-05-15 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10846835000139 | K070242 | 000 |