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Mariner 11719503

by Angiodynamics, Inc.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

22 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK173762 Date18 Jul 2018DecidedStatusActive
United StatesGUDID listing NumberH787117195030 UDI-DI Date15 Sep 2016ListedStatusListed GUDID: in commercial distribution

Recalls

23 recalls · 22 ongoing · FDA

  • 20 recalls, same reason

    • Ongoing Z-1862-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1873-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1863-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1866-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1872-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1859-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1871-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1858-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1860-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1864-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1875-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1870-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1856-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1869-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1867-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1865-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1874-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1861-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1857-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1868-2026 FDA Class II initiated 3 Mar 2026

    The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

  • 2 recalls, same reason

    • Ongoing Z-2453-2024 FDA Class II initiated 18 Jun 2024
    • Ongoing Z-2454-2024 FDA Class II initiated 18 Jun 2024

    Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner pouch label may contain information for a different model (catheter length)

    • Terminated Z-0742-2018 FDA Class II initiated 22 Sep 2017

    Product was placed into distribution prior to completion of all required post sterilization release activities.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Mariner
Generic name
Angiographic catheter, single-use
Model / reference
11719503
Primary DI / UDI-DI
H787117195030
510(k) Number
FDA product code
DQO
GMDN term
Angiographic catheter, single-use
Device class
Class II
Regulation number
870.1200
GUDID distribution status
In Commercial Distribution
Size
Length — 100 Centimeter
Catheter Gauge — 5 French

Related devices

Category: Angiographic catheter, single-use

Cleared under the same submission (K112452)

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Cleared under the same submission (K161596)

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Cleared under the same submission (K173762)

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Other devices from Angiodynamics, Inc.

See all devices from Angiodynamics, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date

Other properties (10)

  • Sterilise before use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Manufacturing date: No