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Mariner 11709227

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

18 ongoing

This device is named in the recall

Documents

510(k) K173762

FDA submission, from GUDID

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 StatesGUDID listing NumberH787117092270 UDI-DI Date29 Apr 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK173762 Date18 Jul 2018DecidedStatusActive

Recalls

18 recalls · 18 ongoing · FDA

  • 16 recalls, same reason

    • Ongoing Z-1862-2026 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-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-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-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)

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  • Withdrawn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
11709227
Primary DI / UDI-DI
H787117092270
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
Outer Diameter — 1.4 Millimeter
Length — 65 Centimeter
Catheter Gauge — 4 French

Related devices

Category: Angiographic catheter, single-use

Cleared under the same submission (K173762)

Show all (12)

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