The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Reprocessed 3d Diagnostic Ultrasound Catheter.
| Device ID | K110076 |
| 510k Number | K110076 |
| Device Name: | REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETER |
| Classification | Reprocessed Intravascular Ultrasound Catheter |
| Applicant | STERILMED, INC. 11400 73RD AVE. NORTH Maple Grove, MN 55369 -5562 |
| Contact | Garrett Ahlborg |
| Correspondent | Garrett Ahlborg STERILMED, INC. 11400 73RD AVE. NORTH Maple Grove, MN 55369 -5562 |
| Product Code | OWQ |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-11 |
| Decision Date | 2011-08-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888551044387 | K110076 | 000 |
| 10888551044370 | K110076 | 000 |
| 10888551044363 | K110076 | 000 |
| 10888551044356 | K110076 | 000 |
| 10888551014458 | K110076 | 000 |
| 10888551014441 | K110076 | 000 |
| 10888551007122 | K110076 | 000 |
| 10888551007115 | K110076 | 000 |