FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VENAFLOW REUSABLE CALF AIRCELL, MODEL 3018, VENAFLOW DISPOSABLE CALF COVER, MODEL 3017
K Number: K023800
·
Decision Feb 10, 2003
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
349
Applicant Total
11
Review Days
88
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Basic Information
- Device Name
- VENAFLOW REUSABLE CALF AIRCELL, MODEL 3018, VENAFLOW DISPOSABLE CALF COVER, MODEL 3017
- K Number
- K023800
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Aircast, Inc.
- Date Received
- November 14, 2002
- Decision Date
- February 10, 2003
- Product Code
- JOW
- 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 |
|---|---|---|---|
| JOW | Sleeve, Limb, Compressible | FDA class 2 | Cardiovascular |
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Other Clearances by Aircast, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K024019 | ARTERIALFLOW SYSTEM, MODEL 32A | Jun 3, 2003 | Substantially Equivalent |
| K992454 | VENAFLOW SYSTEM, MODEL 30A | Jan 13, 2000 | Substantially Equivalent |
| K964238 | AIRCAST VENA FLOW STERILE DISPOSABLE CUFFS | Sep 8, 1997 | Substantially Equivalent |
| K961676 | AIRCAST VENAFLOW SYSTEM (MODIFICATION) | Mar 28, 1997 | Substantially Equivalent |
| K933977 | AIRCAST EDEMAFLOW SYSTEM | Dec 7, 1993 | Substantially Equivalent |
| K932900 | AIRCAST VENAFLOW SYSTEM | Oct 25, 1993 | Substantially Equivalent |
| K925677 | AUTOCHILL ACCESSORY KIT | Apr 14, 1993 | Substantially Equivalent |
| K812094 | AIRCAST PNEUMATIC KNEE BRACE | Aug 13, 1981 | Substantially Equivalent |
| K810288 | AIRCAST TENNIS ARM BAND | Feb 12, 1981 | Substantially Equivalent |
| K780979 | AIRSTIRRUP PNEUMATIC ANKLE BRACE | Jun 30, 1978 | Substantially Equivalent |