(294 days)
The Medtronic Attain Command™ 6250 Left Heart Delivery Systems and the Medtronic Attain Command™ 6250 Guide Catheters for Left Heart Delivery are intended for introducing transvenous devices and leads into vessels of the left heart via the coronary sinus
The Attain Command™ Left Heart Delivery Systems contain two guide catheters, one guide catheter dilator, one guide wire, one valve and one slitter. It is designed to access the coronary sinus and the chambers of the heart using the guidewire to access the vein, the valve to reduce blood loss during the implant procedure, the guide catheter to introduce a transvenous device, the guide catheter dilator to facilitate catheter passage and the slitter to remove the guide catheter.
The Attain Command™ Left Heart Delivery Systems are available in two models:
• Attain Command™ 6250C Left Heart Delivery System
• Attain Command™ 6250S Left Heart Delivery System.
All components with the exception of the two guide catheters are identical in both models. The guide catheters are different in each model with respect to the guide catheter shape and length.
The Attain Command™ Guide Catheters for Left Heart Delivery are individual packs, each containing one guide catheter and one guide catheter dilator. It is also designed to access the coronary sinus and the chambers of the heart using the guide catheter to introduce a transvenous device and the guide catheter dilator to facilitate catheter passage.
The Attain Command™ Guide Catheters for Left Heart Delivery are available in eleven models as follows:
- · Attain Command ™ 6250-45S Guide Catheter for Left Heart Delivery
- · Attain Command ™ 6250-50S Guide Catheter for Left Heart Delivery
- · Attain Command " 6250-57S Guide Catheter for Left Heart Delivery
- · Attain Command ™ 6250-AM Guide Catheter for Left Heart Delivery
- · Attain Command " 6250-EH Guide Catheter for Left Heart Delivery
- TH 6250-EHXL Guide Catheter for Left Heart Delivery · Attain Command
- ти 6250-MB2 Guide Catheter for Left Heart Delivery · Attain Command
- · Attain Command ™ 6250-MB2X Guide Catheter for Left Heart Delivery
- 6250-MP Guide Catheter for Left Heart Delivery · Attain Command T
- · Attain Command ™ 6250-MPR Guide Catheter for Left Heart Delivery
- · Attain Command ™ 6250-MPX Guide Catheter for Left Heart Delivery
Each model is different with respect to the guide catheter shape and length and the dilator length
This 510(k) summary describes a medical device submission for the Medtronic Attain Command™ 6250 Left Heart Delivery Systems and Attain Command™ 6250 Guide Catheters for Left Heart Delivery. The document focuses on demonstrating substantial equivalence to previously cleared predicate devices through mechanical, functional, and biocompatibility testing.
Here's an breakdown of the requested information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical integrity | Met all specified design and performance requirements. |
| Functional performance | Met all specified design and performance requirements. |
| Biocompatibility | Verified, consistent with ISO 10993-1:2003 for external communicating devices with |
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).