Visions 8.2F PV Ultrasonic Imaging Catheter (Model 88900)
FDA 510(k) K982329 · Endosonics Corp.
510(k) numberK982329
Submission
- Device name
- Visions 8.2F PV Ultrasonic Imaging Catheter (Model 88900)
- Applicant
- Endosonics Corp.
Rancho Cordova,, CA, US - Received
- July 2, 1998
- Decision date
- January 14, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K950276 | Microsound 6.6F Diagnostic Imaging Catheter Model 50302, Intravascular Ultrasound…IYO · Traditional | 09/22/1995SE |
| K944004 | Visions 2.9F Ultrasonic Imaging Catheter (Model 84300)IYO · Traditional | 05/04/1995SE |
| K926252 | Cathscanner II Intravascular Ultrasonic Imaging SyIYO · Traditional | 10/25/1993SE |
| K924980 | Cathscanner Visions Microrail Ultra Imag CathITX · Traditional | 01/15/1993SE |
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Questions and answers
When was Visions 8.2F PV Ultrasonic Imaging Catheter (Model 88900) cleared by the FDA?
Visions 8.2F PV Ultrasonic Imaging Catheter (Model 88900) (K982329) received a 510(k) decision of Substantially Equivalent on January 14, 1999, 196 days after the submission was received.
What is the product code of K982329?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.