Saffron NM Guiding Catheter
by Neich Medical (Shenzhen) Company Limited
510(k) K030715
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK030715 | Date24 Apr 2003 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DQY
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1250
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Saffron NM Guiding Catheter is a flexible intravascular catheter classified under product code DQY. It is designed as a guiding catheter for use in interventional cardiology procedures, providing a pathway for the introduction of diagnostic or therapeutic devices into the venous system. Its structure supports precise navigation and positioning within blood vessels, aiding in procedures such as coronary angiography or percutaneous interventions. The device is intended for temporary use during controlled medical interventions.
This catheter is supplied as a single-use, non-sterile device, requiring sterilization prior to use. It is intended for use in clinical settings where vascular access and interventional procedures are performed. The device is regulated under 21 CFR 870.1250 and was cleared through the FDA 510(k) pathway in 2003, demonstrating substantial equivalence to a predicate device. No additional regulatory status beyond the stated FDA clearance is implied.
Other devices from Neich Medical (Shenzhen) Company Limited
Questions
AI-generated answers, 1 Oct 2026
What is the Saffron NM Guiding Catheter used for?
The Saffron NM Guiding Catheter is designed for interventional cardiology procedures, providing a flexible pathway for introducing diagnostic or therapeutic devices into the venous system. Its structure ensures accurate navigation and positioning within blood vessels, making it suitable for procedures like coronary angiography or percutaneous interventions. It is intended for temporary use during controlled medical interventions.
Is the Saffron NM Guiding Catheter sterile when supplied?
No, the Saffron NM Guiding Catheter is supplied as a non-sterile device. It must be sterilized prior to use in clinical settings to ensure patient safety and compliance with medical standards.
How is the Saffron NM Guiding Catheter regulated?
The Saffron NM Guiding Catheter is regulated under 21 CFR 870.1250 and was cleared through the FDA 510(k) pathway in 2003. It was determined to be substantially equivalent to a predicate device by the FDA’s Cardiovascular Advisory Committee, ensuring its compliance with safety and performance standards.
Is the Saffron NM Guiding Catheter intended for single-use or reuse?
The Saffron NM Guiding Catheter is explicitly designed for single-use only. This design choice minimizes infection risks and ensures consistent performance during procedures, aligning with best practices in interventional cardiology.
What product code classification does the Saffron NM Guiding Catheter fall under?
The Saffron NM Guiding Catheter is classified under product code DQY, which categorizes it as a guiding catheter for intravascular use in interventional cardiology procedures.