The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Acunav Diagnostic Ultrasound Catheter 8f And 10f.
| Device ID | K071234 |
| 510k Number | K071234 |
| Device Name: | ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F |
| Classification | Catheter, Ultrasound, Intravascular |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 1230 SHOREBIRD WAY P O BOX 7393 Mountain View, CA 94039 -7393 |
| Contact | Sheila W Pickering |
| Correspondent | Sheila W Pickering 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-03 |
| Decision Date | 2007-06-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869001043 | K071234 | 000 |
| 04056869001036 | K071234 | 000 |
| 04056869001029 | K071234 | 000 |
| 04056869001012 | K071234 | 000 |