A-V IMPULSE SYSTEM MODEL 6060
FDA 510(k) clearance K951683 · decided 1995-10-26
Clearance details
- K-number
- K951683
- Device name
- A-V IMPULSE SYSTEM MODEL 6060
- Applicant
- Novamedix , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1995-04-11
- Decision date
- 1995-10-26
- Days to decision
- 198 days
- Clearance type
- Traditional
- Product code
- JOW
- Device class
- 2
- Regulation number
- 870.5800
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AVI Sterile Impad Rigid Sole Foot Cover, Right Foot Product Code:6066 recall (Z-2656-2010) | Covidien LP | 2010-10-01 |
| AVI Sterile Impad Rigid Sole Foot Cover, Left Foot Product Code:6067 recall (Z-2657-2010) | Covidien LP | 2010-10-01 |