FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDTRONIC EVERST 30 INFLATION DEVICE/SURVIVAL KIT
K Number: K960983
·
Decision May 30, 1996
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
56
Applicant Total
21
Review Days
80
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Basic Information
- Device Name
- MEDTRONIC EVERST 30 INFLATION DEVICE/SURVIVAL KIT
- K Number
- K960983
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1650
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronics Interventional Vascular
- Date Received
- March 11, 1996
- Decision Date
- May 30, 1996
- Product Code
- MAV
- 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 |
|---|---|---|---|
| MAV | Syringe, Balloon Inflation | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MAV), ordered by most recent decision date.
Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest 20 Survival Kit containing:1. Everest 20 Device with 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC2205P); Everest 30 Survival Kit containing:1. Everest 30 Device with 3-way Stopcock, 2. Piton Y-Adaptor,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC3205P)
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Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit
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FDA Class 2
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basixTOUCH40 Inflation Syringe
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Fluent Inflation Device
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MASTRO PLUS BALLOON IN-DEFLATION DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Medtronics Interventional Vascular
| K Number | Device Name | ||
|---|---|---|---|
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| K980973 | MEDTRONIC ANGIOGRAPHIC CATHETER | Dec 10, 1998 | Substantially Equivalent |
| K982883 | MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER | Sep 4, 1998 | Substantially Equivalent |
| K981198 | MEDTRONIC ZUMA GUIDING CATHETER | Aug 7, 1998 | Substantially Equivalent |
| K972944 | MEDTRONIC MUSTANG SUPER FLOPPY GUIDE WIRE/FLOPPY GUIDE WIRE/INTERMEDIATE GUIDE WIRE/STANDARD GUIDE WIRE/EXTRA SUPPORT | Nov 3, 1997 | Substantially Equivalent |
| K961917 | MEDTRONIC MUSTANG STEERABLE GUIDE WIRE (M-45FR, M45FX) | Nov 20, 1996 | Substantially Equivalent |
| K955651 | MEDTRONIC SHERPA GUIDING CATHETER | Jan 22, 1996 | Substantially Equivalent |
| K950490 | MEDTRONIC GC IV CORONARY GUIDING CATHETER | Nov 21, 1995 | Substantially Equivalent |
| K950179 | MEDTRONIC(R) GC III CORONARY GUIDING CATHETER | Jul 25, 1995 | Substantially Equivalent |
| K950026 | MEDTRONIC(R) 8.2 FRENCH SHERPA(R) SUPER PEAK FLOW(TM) CORONARY GUIDING CATHETER | Apr 5, 1995 | Substantially Equivalent |