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Respiguide Delivery System

by ZOLL Respicardia, Inc. United States EUDAMED510(k)GUDID

Ref 7000-K, 7000-S, 7120-S, 7090-S, 7090-K510(k) K130378

Product code DQYEMDN J0206

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/AIMDD EUDAMED NumberB-00857688007285 Basic UDI-DIDate3 Apr 2025RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-00857688007285 Basic UDI-DIDate3 Apr 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00857688007285 UDI-DIDate30 Apr 2018ListedStatusIn distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK130378 Date17 Oct 2013ClearedStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring (legacy directive)
  • Not covered
  • European Union CE/AIMDD, CE/MDD Expiring (legacy directive)
  • United States FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · GUDID · synced 22 Oct 2026

Generic Name
Vascular guide-catheter, single-use
Model / Reference
7000-K, 7000-S, 7120-S, 7090-S, 7090-K
Primary DI / UDI-DI
00857688007285, 00857688007254, 00857688007278, 00857688007261, 00857688007292
Basic UDI-DI
B-00857688007285, B-00857688007254, B-00857688007278, B-00857688007261, B-00857688007292
510(k) Number
FDA Product Code
DQO
EMDN Code
J0206 Frenic nerve implantable neurostimulators
GMDN Term
Vascular guide-catheter, single-use
Device Class
Class AIMDD EUDAMED
Class II GUDID
Regulation Number
870.1200
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class AIMDD
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000023953
FDA applicant
Respicardia
Authorised representative
ICON (LR) Limited IE-AR-000006507

Other devices from ZOLL Respicardia, Inc.

See all devices from ZOLL Respicardia, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date
Other properties (16)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: 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

Sources (7)

  • EUDAMED fc191d8c-a4d5-4b55-bd5e-4cbb86de171a 85 fields · synced 22 Oct 2026
  • EUDAMED 00857688007254|B-00857688007254 61 fields · synced 17 May 2026
  • EUDAMED 00857688007278|B-00857688007278 61 fields · synced 17 May 2026
  • EUDAMED 00857688007261|B-00857688007261 61 fields · synced 18 May 2026
  • EUDAMED 00857688007292|B-00857688007292 61 fields · synced 18 May 2026
  • FDA UDI a6c4b55a-db17-4454-8985-8b620a0aced8 35 fields · synced 30 May 2026
  • FDA 510(k) K130378 1 fields · synced 18 May 2026