Endosonics Corp.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Endosonics Corp.” (first 1989, latest 2000), across 8 product codes in 2 review panels. Median 510(k) review time under this name: 106 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 5 | 5 |
| ITX | Transducer, Ultrasonic, Diagnostic | 3 | 3 |
| DXO | Transducer, Pressure, Catheter Tip | 2 | 2 |
| DQO | Catheter, Intravascular, Diagnostic | 1 | 1 |
| DQX | Wire, Guide, Catheter | 1 | 1 |
| DXK | Echocardiograph | 1 | 1 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 1 | 1 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 1 | 1 |
Review panels
- Radiology (9)
- Cardiovascular (6)
Most recent Endosonics Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K000820 | AVANAR F/X 2.9F INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 85700 | DQO | 2000-06-05 | 84 |
| K990271 | ENDOSONICS TRAK BACK DEVICE | DQX | 1999-08-30 | 214 |
| K982329 | VISIONS 8.2F PV ULTRASONIC IMAGING CATHETER (MODEL 88900) | ITX | 1999-01-14 | 196 |
| K965223 | RESOLVE OPTION FOR THE ORACLE IN VISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM | IYO | 1998-06-29 | 545 |
| K963290 | COLORFLO OPTION FOR THE ORACLE INVISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM | IYO | 1997-08-06 | 350 |
| K962293 | ENDOSONICS AUTOMATIC PULL BACK DEVICE | ITX | 1996-09-16 | 94 |
| K950276 | MICROSOUND 6.6F DIAGNOSTIC IMAGING CATHETER MODEL 50302, INTRAVASCULAR ULTRASOUND IMAGING SYSTEM | IYO | 1995-09-22 | 242 |
| K944004 | VISIONS 2.9F ULTRASONIC IMAGING CATHETER (MODEL 84300) | IYO | 1995-05-04 | 261 |
| K926252 | CATHSCANNER II INTRAVASCULAR ULTRASONIC IMAGING SY | IYO | 1993-10-25 | 315 |
| K924980 | CATHSCANNER VISIONS MICRORAIL ULTRA IMAG CATH | ITX | 1993-01-15 | 106 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Endosonics Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Endosonics Corp.?
FDA lists 15 510(k) clearances under the applicant name “Endosonics Corp.” (first 1989, latest 2000), across 8 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Endosonics Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Endosonics Corp. is 106 days.
Which FDA product codes appear under Endosonics Corp.?
The most frequent FDA product codes under this applicant name are IYO (System, Imaging, Pulsed Echo, Ultrasonic, 5); ITX (Transducer, Ultrasonic, Diagnostic, 3); DXO (Transducer, Pressure, Catheter Tip, 2).
Next steps
- See all 15 Endosonics Corp. clearances with predicates and recalls
- Run predicate analysis for product code IYO, Endosonics Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.