Endosonics Corp.
Rockville, MD, US
Endosonics Corp. appears in FDA device records in Rockville, MD. FDA records list 15 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 15
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 15 510(k) clearances for Endosonics Corp. between 1989 and 2000. The busiest year on record is 1989, with 3. The most recent is 2000, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 3 |
| 1990 | 1 |
| 1991 | 1 |
| 1993 | 2 |
| 1995 | 2 |
| 1996 | 1 |
| 1997 | 1 |
| 1998 | 1 |
| 1999 | 2 |
| 2000 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K000820 | AVANAR F/X 2.9F INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 85700 | DQO | Substantially Equivalent | |
| K990271 | ENDOSONICS TRAK BACK DEVICE | DQX | Substantially Equivalent | |
| K982329 | VISIONS 8.2F PV ULTRASONIC IMAGING CATHETER (MODEL 88900) | ITX | Substantially Equivalent | |
| K965223 | RESOLVE OPTION FOR THE ORACLE IN VISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM | IYO | Substantially Equivalent | |
| K963290 | COLORFLO OPTION FOR THE ORACLE INVISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM | IYO | Substantially Equivalent | |
| K962293 | ENDOSONICS AUTOMATIC PULL BACK DEVICE | ITX | Substantially Equivalent | |
| K950276 | MICROSOUND 6.6F DIAGNOSTIC IMAGING CATHETER MODEL 50302, INTRAVASCULAR ULTRASOUND IMAGING SYSTEM | IYO | Substantially Equivalent | |
| K944004 | VISIONS 2.9F ULTRASONIC IMAGING CATHETER (MODEL 84300) | IYO | Substantially Equivalent | |
| K926252 | CATHSCANNER II INTRAVASCULAR ULTRASONIC IMAGING SY | IYO | Substantially Equivalent | |
| K924980 | CATHSCANNER VISIONS MICRORAIL ULTRA IMAG CATH | ITX | Substantially Equivalent | |
| K911384 | CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600 | DXK | Substantially Equivalent | |
| K902454 | CATHSCANNER(R) PTA BALLOON DILATATION CATHETER | LIT | Substantially Equivalent | |
| K894747 | PRECEPT-GT(TM) MICROSENSOR PRESSURE MONITOR CATH. | DXO | Substantially Equivalent | |
| K893042 | CATHSCANNER(R) INTRAVASCULAR ULTRA IMAGING SYSTEM | IYN | Substantially Equivalent | |
| K890492 | PRECEPT-PT(TM) MICROSENSOR PRESSURE MONITOR CATH. | DXO | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain