FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit
K Number: K153038
·
Decision Apr 13, 2016
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
56
Applicant Total
209
Review Days
177
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Basic Information
- Device Name
- Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit
- K Number
- K153038
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1650
- Medical Specialty
- Cardiovascular
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Medtronic, Inc.
- Date Received
- October 19, 2015
- Decision Date
- April 13, 2016
- 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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MASTRO PLUS BALLOON IN-DEFLATION DEVICE
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FDA 510(k)
FDA Class 2
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