6F Z4 GUIDE CATHETER— 510(k) K042489
Substantially EquivalentMedtronic Vascular
FDA 510(k) clearance K042489 for 6F Z4 GUIDE CATHETER, Substantially Equivalent on 2004-12-13. 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 K042489
K-number listed on FDA's recall record- Z-2562-2019 — SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA 55CM .070", REF SA6IMAK. for cardiovascular use
- Z-2563-2019 — SHERPA NX ACTIVE GUIDING CATHETER, 6F, RDND1 55CM .070", REF SA6RDND1K. for cardiovascular use
- Z-2564-2019 — SHERPA NX ACTIVE GUIDING CATHETER, 6F, 3DRC 100CM .070", REF SA63DRC. for cardiovascular use
- Z-2565-2019 — SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL1.0 110CM .070", REF SA6AL10A. for cardiovascular use
- Z-2566-2019 — SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL1.0 90CM.070", REF SA6AL10D. for cardiovascular use
- Z-2567-2019 — SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL3.0 110CM.070", REF SA6AL30A. for cardiovascular use
- Z-2568-2019 — SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL.75 110CM.070", REF SA6AL75A. for cardiovascular use
- Z-2569-2019 — SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR1.0 100CM.070", REF SA6AR10. for cardiovascular use
- Z-2570-2019 — SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR1.0SH 100CM.070", REF SA6AR10SH. for cardiovascular use
- Z-2571-2019 — SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR2.0, 100CM.070", REF SA6AR20. for cardiovascular use
- Z-2572-2019 — SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR2.0 SH, 100CM.070", REF SA6AR20SH. for cardiovascular use
- Z-2573-2019 — SHERPA NX ACTIVE GUIDING CATHETER, 6F, CHAMP0.5, 100CM.070", REF SA6CHAMP05. for cardiovascular use
- Z-2574-2019 — SHERPA NX ACTIVE GUIDING CATHETER, 6F, CHAMP0.5 SH, 100CM.070", REF SA6CHAMP05SH. for cardiovascular use
- Z-2575-2019 — SHERPA NX ACTIVE GUIDING CATHETER, 6F, CHAMP2.0, 55CM.070", REF SA6CHAMP20K. for cardiovascular use
- Z-2576-2019 — SHERPA NX ACTIVE GUIDING CATHETER, 6F, EBU3.5, 110CM.070", REF SA6EBU35A. for cardiovascular use
- Z-2577-2019 — SHERPA NX ACTIVE GUIDING CATHETER, 6F, EBU3.5, 90CM.070", REF SA6EBU35D. for cardiovascular use
- Z-2578-2019 — SHERPA NX ACTIVE GUIDING CATHETER, 6F, EBU4.0, 110CM.070", REF SA6EBU40A. for cardiovascular use
- Z-2579-2019 — SHERPA NX ACTIVE GUIDING CATHETER, 6F, FL4.0, 100CM.070", REF SA6FL40. for cardiovascular use
- Z-2580-2019 — SHERPA NX ACTIVE GUIDING CATHETER, 6F, FL4.0 SH, 100CM, 070", REF SA6FL40SH. for cardiovascular use
- Z-2581-2019 — SHERPA NX ACTIVE GUIDING CATHETER, 6F, HSI, 100CM, 070", REF SA6HSI. for cardiovascular use
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K042489.
Data sourced from openFDA. This site is unofficial and independent of the FDA.