FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDOSONICS AUTOMATIC PULL BACK DEVICE
K Number: K962293
·
Decision Sep 16, 1996
Classifications
1
FEI Numbers
398
Registration Numbers
399
Same Product Code
408
Applicant Total
15
Review Days
94
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ENDOSONICS AUTOMATIC PULL BACK DEVICE
- K Number
- K962293
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Endosonics Corp.
- Date Received
- June 14, 1996
- Decision Date
- September 16, 1996
- Product Code
- ITX
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ITX), ordered by most recent decision date.
ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)
FDA 510(k)
FDA Class 2
·Radiology
ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)
FDA 510(k)
FDA Class 2
·Radiology
Mendaera Guidance System
FDA 510(k)
FDA Class 2
·Radiology
Accuro® 3S Needle Guide Kit
FDA 510(k)
FDA Class 2
·Radiology
Ultrasound Transducer Cover
FDA 510(k)
FDA Class 2
·Radiology
UltraDrape UGPIV Barrier and Securement (34-15)
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Endosonics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K000820 | AVANAR F/X 2.9F INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 85700 | Jun 5, 2000 | Substantially Equivalent |
| K990271 | ENDOSONICS TRAK BACK DEVICE | Aug 30, 1999 | Substantially Equivalent |
| K982329 | VISIONS 8.2F PV ULTRASONIC IMAGING CATHETER (MODEL 88900) | Jan 14, 1999 | Substantially Equivalent |
| K965223 | RESOLVE OPTION FOR THE ORACLE IN VISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM | Jun 29, 1998 | Substantially Equivalent |
| K963290 | COLORFLO OPTION FOR THE ORACLE INVISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM | Aug 6, 1997 | Substantially Equivalent |
| K950276 | MICROSOUND 6.6F DIAGNOSTIC IMAGING CATHETER MODEL 50302, INTRAVASCULAR ULTRASOUND IMAGING SYSTEM | Sep 22, 1995 | Substantially Equivalent |
| K944004 | VISIONS 2.9F ULTRASONIC IMAGING CATHETER (MODEL 84300) | May 4, 1995 | Substantially Equivalent |
| K926252 | CATHSCANNER II INTRAVASCULAR ULTRASONIC IMAGING SY | Oct 25, 1993 | Substantially Equivalent |
| K924980 | CATHSCANNER VISIONS MICRORAIL ULTRA IMAG CATH | Jan 15, 1993 | Substantially Equivalent |
| K911384 | CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600 | Jun 25, 1991 | Substantially Equivalent |