FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRI ADAPTER W/ADJUSTABLE HEMOSTASIS VALVES
K Number: K901247
·
Decision Jul 31, 1990
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
98
Applicant Total
17
Review Days
138
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Basic Information
- Device Name
- TRI ADAPTER W/ADJUSTABLE HEMOSTASIS VALVES
- K Number
- K901247
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1240
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Intec Medical, Inc.
- Date Received
- March 15, 1990
- Decision Date
- July 31, 1990
- Product Code
- DYG
- Advisory Committee
- Cardiovascular
- 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 |
|---|---|---|---|
| DYG | Catheter, Flow Directed | FDA class 2 | Cardiovascular |
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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 |
| K894925 | AMCATH URETERAL DILATORS MODELS 7100,7110,7120 | Dec 13, 1989 | 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 |