FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BSC, SONICATH ULTRA IMAGING CATHETER 3.2F/20MHZ(37410/456221 & BSC, SONICATH ULTRA IMAGING CATHETER 2.9F/20MHZ/37411/
K Number: K970049
·
Decision Jun 20, 1997
Classifications
1
FEI Numbers
398
Registration Numbers
399
Same Product Code
408
Applicant Total
19
Review Days
165
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Basic Information
- Device Name
- BSC, SONICATH ULTRA IMAGING CATHETER 3.2F/20MHZ(37410/456221 & BSC, SONICATH ULTRA IMAGING CATHETER 2.9F/20MHZ/37411/
- K Number
- K970049
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cardiovascular Imaging Systems, Inc.
- Date Received
- January 6, 1997
- Decision Date
- June 20, 1997
- 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)
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Other Clearances by Cardiovascular Imaging Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K942231 | MICROVIEW II/MICRORAIL II CATHETERS | Aug 1, 1994 | Substantially Equivalent |
| K933517 | AUTOMATIC PULL BACK DEVICE | Oct 15, 1993 | Substantially Equivalent |
| K930232 | CVIS INSIGHT IMAGING GUIDE CATHETER | Jul 21, 1993 | Substantially Equivalent |
| K924922 | CVIS INSIGHT IMAGING CATHETER | Jun 29, 1993 | Substantially Equivalent |
| K930311 | CVIS LONGVIEW | Jun 2, 1993 | Substantially Equivalent |
| K921879 | CBIS CATHETER PULL-BACK DEVICE | Jul 16, 1992 | Substantially Equivalent |
| K921750 | CVIS INSIGHT III SYSTEM | Jul 13, 1992 | Substantially Equivalent |
| K921631 | CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL | Jul 2, 1992 | Substantially Equivalent |
| K921148 | CVIS INSIGHT CATHETERS FOR INTRACARDIAC USE | Jun 16, 1992 | Substantially Equivalent |
| K921147 | CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL USE | Jun 16, 1992 | Substantially Equivalent |