The following data is part of a premarket notification filed by Siemens Medical Solutions Usa Inc. with the FDA for Acunav V Ultrasound Catheter.
| Device ID | K081808 |
| 510k Number | K081808 |
| Device Name: | ACUNAV V ULTRASOUND CATHETER |
| Classification | Catheter, Ultrasound, Intravascular |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA INC. 1230 SHOREBIRD WAY P.O. BOX 7393 Mountain View, CA 94039 -7393 |
| Contact | Shelly Pearce |
| Correspondent | Shelly Pearce SIEMENS MEDICAL SOLUTIONS USA INC. 1230 SHOREBIRD WAY P.O. BOX 7393 Mountain View, CA 94039 -7393 |
| Product Code | OBJ |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-26 |
| Decision Date | 2008-09-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869001050 | K081808 | 000 |