Attain Select 6238TEL Guide Catheter Set for Left-Heart Delivery
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K042194 FDA 510(k)
- FDA Product Code
- DQY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1250 FDA 510(k)
- Regulation Number
- 870.1250 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Attain Select 6238TEL Guide Catheter Set for Left-Heart Delivery is a percutaneous catheter system designed for the delivery of contrast media and transvenous devices to the coronary sinus and left heart venotomy. It is used to facilitate the placement of coronary sinus leads, particularly in complex anatomical scenarios.
Supplied as a sterile, single-use device, this catheter set is intended for use in cardiovascular interventional procedures. It has received FDA 510(k) clearance (K042194) and is classified as a Class II device under product code DQY with special controls. The device is manufactured by Medtronic Vascular and is not indicated for MRI safety or reuse.
Frequently asked questions
What is the Attain Select 6238TEL Guide Catheter Set used for?
It is designed for the percutaneous delivery of contrast media and transvenous devices to the coronary sinus and left heart venotomy, facilitating coronary sinus lead placement in complex anatomical scenarios during cardiovascular interventional procedures.
Is the Attain Select 6238TEL Guide Catheter Set sterile and single-use?
Yes, the device is supplied as a sterile, single-use catheter set and is not indicated for reuse, ensuring patient safety and reducing infection risk during cardiovascular procedures.
What regulatory clearance does the Attain Select 6238TEL Guide Catheter Set have?
The device has received FDA 510(k) clearance under submission number K042194 and is classified as a Class II medical device under product code DQY with special controls.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Attain Select 6238tel Guide Catheter Set for Left-heart Delivery ..., attain select 6238tel guide catheter set for left-heart delivery, K042194 - Attain Select 6238tel Guide Catheter Se..., Attain Select 6238tel Guide Catheter Set for Left-heart Delivery
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K042194 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K042194 24 fields · synced Oct 6, 2026