FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMCATH URETERAL DILATORS MODELS 7100,7110,7120
K Number: K894925
·
Decision Dec 13, 1989
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
55
Applicant Total
17
Review Days
133
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Basic Information
- Device Name
- AMCATH URETERAL DILATORS MODELS 7100,7110,7120
- K Number
- K894925
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5470
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Intec Medical, Inc.
- Date Received
- August 2, 1989
- Decision Date
- December 13, 1989
- Product Code
- EZN
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| EZN | Dilator, Catheter, Ureteral | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Intec Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K911840 | INTERFLO MEDICAL MODEL PA3-H CCO/PAC CATHETER | Jun 3, 1991 | Substantially Equivalent |
| K903217 | TAPERED TIP THE GUIDER CORONARY GUIDING CATHETER | Oct 19, 1990 | Substantially Equivalent |
| K903216 | THE GUIDER CORONARY GUIDING CATHETER | Oct 19, 1990 | Substantially Equivalent |
| K900710 | INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER | Oct 19, 1990 | Substantially Equivalent |
| K903840 | GIANT LUMEN SAFETIP SERIES: ENDOMYOCARDIAL BIOPSY | Oct 16, 1990 | Substantially Equivalent |
| K903906 | PERCUTANEOUS CATHETER INTRODUCER KIT | Sep 26, 1990 | Substantially Equivalent |
| K900998 | INTERVENTIONAL MEDICAL Y ADAPTER W/ADJUST. VALVE | Aug 14, 1990 | Substantially Equivalent |
| K901247 | TRI ADAPTER W/ADJUSTABLE HEMOSTASIS VALVES | Jul 31, 1990 | Substantially Equivalent |
| K860941 | DISPOSABLE HEATED WIRE LOOPS 48 AND 72 | Apr 2, 1986 | Substantially Equivalent |
| K823271 | DISPOSABLE ADULT VO. VENTILATOR CIRCUIT | Dec 22, 1982 | Substantially Equivalent |