MALLEABLE SINGLE STAGE VENOUS CANNULA, MODELS 68112-68140 (15 TOTAL CODES)
FDA 510(k) clearance K022272 · decided 2003-01-08
Clearance details
- K-number
- K022272
- Device name
- MALLEABLE SINGLE STAGE VENOUS CANNULA, MODELS 68112-68140 (15 TOTAL CODES)
- Applicant
- Medtronic Cardiac Surgical Products
- Decision
- Substantially Equivalent
- Date received
- 2002-07-15
- Decision date
- 2003-01-08
- Days to decision
- 177 days
- Clearance type
- Traditional
- Product code
- DWF
- Device class
- 2
- Regulation number
- 870.4210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Grad Rapids, MI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Medtronic Cardiac Surgical Products
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medtronic Venous Cannulae: a) DLP 20 Fr. Malleable Single Stage Venous Cannula, Model Numb recall (Z-1805-2024) | Medtronic Perfusion Systems | 2024-05-10 |
| Medtronic, DLP, DLP Malleable Single Stage Venous Cannulae. Rx Only, Sterilized Using Ethy recall (Z-0810-2012) | 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 |