FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDFLATOR II(TM) DISPOSABLE INFLATION DEVICE
K Number: K940896
·
Decision Aug 11, 1994
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
56
Applicant Total
48
Review Days
168
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Basic Information
- Device Name
- MEDFLATOR II(TM) DISPOSABLE INFLATION DEVICE
- K Number
- K940896
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1650
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medex, Inc.
- Date Received
- February 24, 1994
- Decision Date
- August 11, 1994
- 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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Other Clearances by Medex, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K042432 | PHARMGUARD TOOLBOX, MODEL G6000782 | Jan 4, 2005 | Substantially Equivalent |
| K040899 | MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP | Apr 30, 2004 | Substantially Equivalent |
| K020780 | TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP | May 20, 2002 | Substantially Equivalent |
| K000328 | MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP | May 9, 2000 | Substantially Equivalent |
| K982640 | MEDEX 3000 SERIES SYRINGE INFUSION PUMP | Apr 6, 1999 | Substantially Equivalent - Subject to Tracking Reg. |
| K982123 | CONTRAST CONTROL DEVICE | Jul 21, 1998 | Substantially Equivalent |
| K955231 | MEDFUSION MODEL 2001 SYRINGE INFUSION PUMP | Jul 18, 1996 | Substantially Equivalent - Subject to Tracking Reg. |
| K961404 | MX960 REUSABLE PRESSURE TRANSDUCER | Jun 27, 1996 | Substantially Equivalent |
| K961527 | MX703 AND MX730 CONTINUOUS FLUSH DEVICES | Jun 6, 1996 | Substantially Equivalent |
| K954970 | STOPCOCK & LUER LOCK PLUG | Apr 22, 1996 | Substantially Equivalent |