K024069Substantially Equivalent
One Piece Pediatric Arterial Cannula, Model: 77006, 77106
Medtronic, Inc., Minneapolis MN / Special, Substantially Equivalent
K024069 is the FDA 510(k) clearance record for ONE PIECE PEDIATRIC ARTERIAL CANNULA, MODEL: 77006, 77106, a class II device, cleared for Medtronic Vascular on under FDA product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show 2 recalls naming K024069.
Clearance record
- Decision date
- Received
- (29 days to decision)
- Product code
- DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- Regulation
- 21 CFR 870.4210
- Device class
- Class II
- Review panel
- Cardiovascular
- Applicant
- Medtronic Vascular 7611 Northland Dr., Minneapolis MN
- 510(k) summary
- Summary PDF
- Third party review
- No
Clearances, product code DWF
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 0 |
| December 2025 | 0 |
| January 2026 | 2 |
| February 2026 | 2 |
| March 2026 | 1 |
| April 2026 | 1 |
| May 2026 | 0 |
| June 2026 | 0 |
| July 2026 | 0 |
| August 2026 | 0 |
| September 2026 | 0 |
| October 2026 | 0 |
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