FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTRAVASCULAR IMAGING SYSTEM
K Number: K895159
·
Decision Mar 12, 1990
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
38
Applicant Total
5
Review Days
201
Basic Information
- Device Name
- INTRAVASCULAR IMAGING SYSTEM
- K Number
- K895159
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- INTERTHERAPY, INC.
- Date Received
- August 23, 1989
- Decision Date
- March 12, 1990
- Product Code
- LYK
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| LYK | Angioscope | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LYK), ordered by most recent decision date.
CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CORONARY SINUS ACCESS KIT, MODEL KCS8F-01
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
KSEA FIBERSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
KSEA VASCULAR FIBERSCOPES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by INTERTHERAPY, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K913763 | INTERPRET(TM) CATHETER LINEAR TRANSLATOR | Nov 20, 1991 | Substantially Equivalent |
| K912600 | INTERPRET(TM) INTRAVASCULAR IMAGING CATHETER | Nov 19, 1991 | Substantially Equivalent |
| K910281 | INTRAVASCULAR IMAGING SYSTEM/MODIFIED | May 13, 1991 | Substantially Equivalent |
| K900305 | INTRAVASCULAR IMAGING SYSTEMS | Apr 20, 1990 | Substantially Equivalent |