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LiquID .051 LP Guide Catheter Extension

by Seigla Medical, Inc. EUDAMED510(k)GUDID

Active European Union and United States

510(k) K243691Ref M3000

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0850012180M30006FLPDV Basic UDI-DIDate2 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00850012180043 UDI-DIDate5 May 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK243691 Date4 Apr 2025ClearedStatusActive

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · 510(k) · GUDID

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 EUDAMED
Class 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

3 sources · 2 fields differ

FieldEUDAMED510(k)GUDID
Model / ReferenceEUDAMED
M3000
510(k)
n/a
GUDID
6F LP
Device ClassEUDAMED
Class III
510(k)
Class II
GUDID
Class II

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • 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

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

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