VENOUS CANNULA W/BENT, TIP WIRE
FDA 510(k) clearance K842375 · decided 1984-08-10
Clearance details
- K-number
- K842375
- Device name
- VENOUS CANNULA W/BENT, TIP WIRE
- Applicant
- Dlp, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-06-18
- Decision date
- 1984-08-10
- Days to decision
- 53 days
- Clearance type
- Traditional
- Product code
- DWF
- Device class
- 2
- Regulation number
- 870.4210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medtronic DPL Single Stage Venous Cannula with Metal Tip, used in cardiopulmonary bypass p recall (Z-0908-2013) | Medtronic Inc. Cardiac Rhythm Disease Management | 2013-03-05 |
| Medtronic DLP, DLP Single Stage Venous Cannula w/Right Angle Metal Tip. Rx Only, Sterile E recall (Z-0807-2012) | Medtronic Inc. Cardiac Rhythm Disease Management | 2012-01-18 |
| Medtronic, DLP, DLP Right Angle Single Stage Venous Cannulae. Rx Only, Sterile EO, Nonpyro recall (Z-0809-2012) | Medtronic Inc. Cardiac Rhythm Disease Management | 2012-01-18 |
| Medtronic, Single Stage Venous Cannula, Carmeda Bio-Active Surface Venous Cannula, Sterili recall (Z-0812-2012) | Medtronic Inc. Cardiac Rhythm Disease Management | 2012-01-18 |
| Medtronic Venous Cannula with bent tip wire, for vascular cardiopulmonary bypass. Catalog recall (Z-1923-2008) | Medtronic Perfusion Systems | 2008-07-24 |