The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Soundstar Eco 8f 3d Diagnostic Eco Ultrasound Catheters, Soundstar Eco 8f G 3d Diagnostic Eco Ultrasound Catheters.
| Device ID | K161700 |
| 510k Number | K161700 |
| Device Name: | SoundStar Eco 8F 3D Diagnostic Eco Ultrasound Catheters, SoundStar Eco 8F G 3D Diagnostic Eco Ultrasound Catheters |
| Classification | Reprocessed Intravascular Ultrasound Catheter |
| Applicant | STERILMED, INC. 5010 CHESHIRE PARKWAY STE. 2 Plymouth, MN 55446 |
| Contact | Reuben Lawson |
| Correspondent | Neelu Gibson STERILMED, INC. 5010 CHESHIRE PARKWAY STE. 2 Plymouth, MN 55446 |
| Product Code | OWQ |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-20 |
| Decision Date | 2016-11-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888551045094 | K161700 | 000 |
| 10888551045087 | K161700 | 000 |