Acunav Diagnostic Ultrasound Catheter
FDA 510(k) K992631 · Acuson Corp.
510(k) numberK992631
Submission
- Device name
- Acunav Diagnostic Ultrasound Catheter
- Applicant
- Acuson Corp.
Washington, DC, US - Received
- August 6, 1999
- Decision date
- December 15, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
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| K232573 | INFINITI Ambi Angiographic CatheterDQO · Traditional | Cordis US Corp | 11/21/2023SE |
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| K023772 | Kinetdx Picture Archiving and Communications SystemLLZ · Traditional | 11/22/2002SE |
| K022896 | CSV12 Software ViewerLLZ · Special | 10/03/2002SE |
| K022567 | Sequoia Signature II Diagnostic Ultrasound SystemIYN · Traditional | 08/13/2002SE |
| K021497 | Cypress Ultrasound SystemIYN · Special | 07/09/2002SE |
| K010950 | Cypress SystemIYO · Abbreviated | 06/27/2001SE |
| K002807 | 3D Organ Assessment W/ Magnetic Position SensingIYO · Traditional | 12/01/2000SE |
| K992580 | Fetal Assessment CapIYO · Traditional | 10/18/1999SE |
| K991805 | Aspen Ultrasound with Freestyle Imaging OptionIYN · Traditional | 08/02/1999SE |
| K973767 | Harmonic Imaging with ContrastIYO · Traditional | 12/23/1997SE |
| K973079 | L7 Transducer Used on Aspen Model Ultrasound SystemITX · Traditional | 11/05/1997SE |
Questions and answers
When was Acunav Diagnostic Ultrasound Catheter cleared by the FDA?
Acunav Diagnostic Ultrasound Catheter (K992631) received a 510(k) decision of Substantially Equivalent on December 15, 1999, 131 days after the submission was received.
What is the product code of K992631?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.