SNIPER, MODEL OR-3872XX SERIES
FDA 510(k) clearance K001251 · decided 2000-07-07
Clearance details
- K-number
- K001251
- Device name
- SNIPER, MODEL OR-3872XX SERIES
- Applicant
- Nipro Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2000-04-19
- Decision date
- 2000-07-07
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- DQX
- Device class
- 2
- Regulation number
- 870.1330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Athens, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Regular. AquaLiner Hydrophilic Guid recall (Z-0134-2013) | Nipro Medical Corporation | 2012-10-25 |
| AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Stiff. AquaLiner Hydrophilic Guidew recall (Z-0135-2013) | Nipro Medical Corporation | 2012-10-25 |
| AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Regular. AquaLiner Hydrophilic G recall (Z-0136-2013) | Nipro Medical Corporation | 2012-10-25 |
| AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Stiff. AquaLiner Hydrophilic Gui recall (Z-0137-2013) | Nipro Medical Corporation | 2012-10-25 |
| AquaLiner Hydrophilic Guidewire 0.035" X 180cm, Angle / Regular. AquaLiner Hydrophilic Gui recall (Z-0138-2013) | Nipro Medical Corporation | 2012-10-25 |