PERCUTANEOUS ARTERIAL/VENOUS CANNULA PLACEMENT KIT
FDA 510(k) clearance K875353 · decided 1988-03-22
Clearance details
- K-number
- K875353
- Device name
- PERCUTANEOUS ARTERIAL/VENOUS CANNULA PLACEMENT KIT
- Applicant
- Dlp, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-12-31
- Decision date
- 1988-03-22
- Days to decision
- 82 days
- Clearance type
- Traditional
- Product code
- DWF
- Device class
- 2
- Regulation number
- 870.4210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Grand Rapids, MI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Dlp
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 DLP Femoral Arterial Cannula, models 57414, 57417, and 57421, and DLP Femoral Ca recall (Z-1914-2015) | Medtronic Perfusion Systems | 2015-06-26 |