Telescope Guide Extension Catheter— 510(k) K252390
Substantially EquivalentMedtronic, Ireland
FDA 510(k) clearance K252390 for Telescope Guide Extension Catheter, Substantially Equivalent on 2025-10-29. Applicant: Medtronic, Ireland. Device class: 2.
Clearance details
- Applicant
- Medtronic, Ireland
- 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
- Traditional
- Location
- Galway, IE
Recent devices under product code DQY
view allMore clearances from Medtronic, Ireland
view all- K261428 — NC Euphora Rapid Exchange Balloon Dilatation Catheter
- K261759 — Euphora Rapid Exchange (RX) Balloon Dilatation Catheter
- K251970 — Sprinter Legend Rapid Exchange Balloon Dilatation Catheter
- K250787 — Liberant Thrombectomy System
- K123153 — ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE CATHETERS FOR LEFT HEART DELIVERY,ATTAIN SELECT
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.