ONE PIECE PEDIATRIC ARTERIAL CANNULA, MODEL: 77006, 77106— 510(k) K024069
Substantially EquivalentMedtronic Vascular
FDA 510(k) clearance K024069 for ONE PIECE PEDIATRIC ARTERIAL CANNULA, MODEL: 77006, 77106, Substantially Equivalent on 2003-01-08. Applicant: Medtronic Vascular. Device class: 2.
Clearance details
- Applicant
- Medtronic Vascular
- Product code
- Code DWF
- Device class
- Class 2
- Regulation
- 21 CFR 870.4210
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Minneapolis, MN, US
Recent devices under product code DWF
view allMore clearances from Medtronic Vascular
view all- K232570 — Steerant Super Stiff Guidewire
- K232190 — 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter
- K230156 — 5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter
- K220773 — Everest 20 Inflation Device and 3-way Stopcock (AC2200) +3 more
- K192296 — Medtronic 6F Taiga Guiding Catheter
Adverse events under product code DWF
product code DWF- Death
- 106
- Injury
- 386
- Malfunction
- 2,323
- Total
- 2,815
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K024069
K-number listed on FDA's recall record- Z-2738-2026 — Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass vascular cannula
- Z-0984-2025 — DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K024069.
Data sourced from openFDA. This site is unofficial and independent of the FDA.