ACUNAV DIAGNOSTIC ULTRASOUND CATHETER
FDA 510(k) clearance K992631 · decided 1999-12-15
Clearance details
- K-number
- K992631
- Device name
- ACUNAV DIAGNOSTIC ULTRASOUND CATHETER
- Applicant
- Acuson Corp.
- Decision
- Substantially Equivalent
- Date received
- 1999-08-06
- Decision date
- 1999-12-15
- Days to decision
- 131 days
- Clearance type
- Traditional
- Product code
- DQO
- Device class
- 2
- Regulation number
- 870.1200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Acuson Corp.
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Siemens Medical Solutions USA, Inc., ACUSON AcuNav ultrasound catheters when using SwiftLi recall (Z-1745-2011) | Siemens Medical Solutions USA, Inc. | 2011-03-23 |