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LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter Extension

by Seigla Medical, Inc.

510(k) K220691Ref M1000, M2000

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

1 Dec 2029

CE MDR certificate

FDA recalls

None found

in data synced 22 Oct 2026

Documents

1 certificate

Certifier Intertek Medical Notified Body AB

510(k) K220691↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0850012180M10006F4X Basic UDI-DI Date2 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00850012180005 UDI-DI Date14 Jul 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK220691 Date5 May 2022ClearedStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Trade Name
LiquID 061
LiquID 071
Generic Name
Vascular guide-catheter extension
Model / Ref / Catalog
M1000, M2000, 6F, 7F
Primary DI / UDI-DI
00850012180005, 00850012180012
Basic UDI-DI
0850012180M10006F4X, 0850012180M20007F5F
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
EU market of registration
Germany
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution
Size
Catheter Gauge — 6 French
Catheter Gauge — 7 French

Truth per registry

3 sources · 2 fields differ

FieldEUDAMED510(k)GUDID
Model / ReferenceEUDAMED
M1000
M2000
510(k)
—
GUDID
6F
7F
Device ClassEUDAMED
Class III
510(k)
Class II
GUDID
Class II

Overview

AI-generated summary, 18 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 061 and 071 Guide Catheter Extensions are catheter extensions designed to enhance coronary and peripheral vascular access. These devices are engineered to provide a larger inner diameter and robust structural integrity, facilitating smoother guidewire and catheter passage through complex vascular pathways.

These extensions are intended for use with guide catheters to improve access to specific coronary or peripheral vascular regions. Supplied as single-use devices, they are regulated under FDA 510(k) clearance (K220691) and comply with the EU Medical Device Regulation (MDR). The LiquID 061 and 071 models are sterile, non-reusable, and must be stored under appropriate conditions to maintain sterility before use.

Other devices from Seigla Medical, Inc.

Questions

AI-generated answers, 18 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 are the LiquID 061 and 071 Guide Catheter Extensions primarily used for in clinical practice?

    The LiquID 061 and 071 Guide Catheter Extensions are designed to improve vascular access during coronary and peripheral procedures. Their larger inner diameter and reinforced structure help guide catheters and guidewires through challenging or tortuous blood vessels, making it easier to navigate complex vascular pathways in these areas.

  • Are the LiquID 061 and 071 Guide Catheter Extensions reusable, or are they meant for single-use only?

    These devices are explicitly labeled as single-use only. They are not intended for reuse, and their sterile packaging must remain unopened until immediate use to ensure sterility and safety.

  • How should I store the LiquID 061 and 071 Guide Catheter Extensions before use to maintain their sterility?

    The devices must be stored under appropriate conditions to preserve sterility. This typically means keeping them in their original, sealed packaging away from moisture, extreme temperatures, and contamination until ready for use.

  • What regulatory pathways have the LiquID 061 and 071 Guide Catheter Extensions followed in the U.S. and Europe?

    In the U.S., these extensions received FDA clearance through a 510(k) submission (K220691) and were deemed substantially equivalent to a predicate device. They also comply with the EU Medical Device Regulation (MDR), ensuring they meet stringent European standards for safety and performance.

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