LiquID .051 LP Guide Catheter Extension
by Seigla Medical, Inc. EUDAMED510(k)GUDID
Active
510(k) K243691Ref M3000
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number0850012180M30006FLPDV | Date2 Apr 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00850012180043 | Date5 May 2025 | StatusListed |
| United States | FDA 510(k)SESE 510(k) | NumberK243691 | Date4 Apr 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Certificates
- 28620207793 Active
Technical documentation EU MDR
- Notified body
- Intertek Medical Notified Body AB 2862
- Issued
- 17 Mar 2025
- Expires
- 1 Dec 2029
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Trade Name
- LiquID 051 LP
- Generic Name
- Vascular guide-catheter extension
- Model / Ref / Catalog
- M3000, 6F LP
- Primary DI / UDI-DI
- 00850012180043
- Basic UDI-DI
- 0850012180M30006FLPDV
- 510(k) Number
- FDA Product Code
- DQY
- EMDN Code
- C0104010202 Cardiac angiography guide catheters
- GMDN Term
- Vascular guide-catheter extension
- Device Class
- Class III EUDAMEDClass II 510(k)GUDID
- Regulation
- 21 CFR Part 870.1250
- Market of Registration
- Germany
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
- GUDID distribution status
- In Commercial Distribution
- Size
- Catheter Gauge — 6 French
Truth per registry
| Field | EUDAMED | 510(k) | GUDID |
|---|---|---|---|
| Model / Reference | M3000 | n/a | 6F LP |
| Device Class | Class III | Class II | Class II |
Overview
AI-generated summary, 20 Sep 2026
The LiquID .051 LP Guide Catheter Extension is a guide catheter extension designed to extend the length of existing guide catheters during vascular interventions. It is classified as a catheter extension under the FDA’s Product Code DQY, intended for use in cardiovascular procedures to enhance catheter reach and stability. Constructed for compatibility with .051-inch LP guide catheters, it provides additional support during interventions such as stent placement in venous systems. The device is engineered to balance flexibility and strength, ensuring reliable performance in complex anatomical pathways.
This extension is supplied as a single-use, non-sterile device and is intended for use in controlled clinical settings such as catheterization labs. It is not MRI-safe and must be handled with sterile techniques prior to use. The device is authorized under FDA 510(k) clearance (K243691) and meets the requirements of the EU Medical Device Regulation (MDR). Storage should follow manufacturer guidelines to maintain integrity, and compatibility is confirmed for use with standard .051-inch LP guide catheters as specified in the design.
Other devices from Seigla Medical, Inc.
Questions
AI-generated answers, 20 Sep 2026
What is the primary purpose of the LiquID .051 LP Guide Catheter Extension in vascular procedures?
The LiquID .051 LP Guide Catheter Extension is designed to extend the length of existing .051-inch LP guide catheters during vascular interventions, such as stent placement in venous systems. Its purpose is to enhance catheter reach and stability, ensuring reliable performance in complex anatomical pathways where additional support is needed.
Is the LiquID .051 LP Guide Catheter Extension intended for reuse, or is it meant for single-use only?
The device is explicitly supplied as a single-use item, meaning it is intended for one-time use in controlled clinical settings like catheterization labs. This design ensures patient safety and sterility, as reuse is not recommended or supported.
How should the LiquID .051 LP Guide Catheter Extension be prepared before use in a procedure?
The extension is non-sterile as supplied, so it must be handled using sterile techniques prior to use in a procedure. This includes proper cleaning, sterilization (if applicable), and adherence to manufacturer guidelines to maintain device integrity and ensure a sterile field during the intervention.
What types of guide catheters is this extension compatible with, and how does it differ from standard guide catheters?
The LiquID .051 LP Guide Catheter Extension is specifically engineered for compatibility with .051-inch LP guide catheters. Unlike standard guide catheters, it provides additional length and support to improve reach and stability during procedures, particularly in challenging venous pathways where extra reinforcement is beneficial.
What storage instructions should be followed to maintain the device’s integrity before use?
The device should be stored according to the manufacturer’s guidelines to preserve its structural integrity. While specific storage conditions aren’t detailed here, typical best practices for catheter extensions—such as protecting from physical damage, extreme temperatures, and contamination—should be followed to ensure the device remains functional and safe for use.
Properties
Other properties (18)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No