Z3 GUIDE CATHETER— 510(k) K021256
Substantially EquivalentMedtronic Vascular
FDA 510(k) clearance K021256 for Z3 GUIDE CATHETER, Substantially Equivalent on 2002-05-17. Applicant: Medtronic Vascular. Device class: 2.
Clearance details
- Applicant
- Medtronic Vascular
- Product code
- Code DQY
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Danvers, MA, US
Recent devices under product code DQY
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 DQY
product code DQY- Death
- 464
- Injury
- 4,489
- Malfunction
- 13,721
- Other
- 2
- Total
- 18,676
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 K021256
K-number listed on FDA's recall record- Z-1245-2021 — Medtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35
- Z-1246-2021 — Medtronic 6F Launcher Guide Catheter 100 cm JR 4.0 Model Number: LA6JR40
- Z-1247-2021 — Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375
- Z-1248-2021 — Medtronic 6F Launcher Guide Catheter 100 cm EBU 3.0 Model Number: LA6EBU30
- Z-0205-2015 — Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K
- Z-1564-2013 — Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, 8F and Model # LA6IMAD, Lot # 0006724224, 6F Product Usage: The Medtronic Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K021256.
Data sourced from openFDA. This site is unofficial and independent of the FDA.