Skip to content

AccuVu 13709106

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

20 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 · Traditional NumberK161596 Date28 Apr 2017DecidedStatusActive
United StatesGUDID listing NumberH787137091060 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution

Recalls

21 recalls · 20 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.

    • 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  • Withdrawn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
AccuVu
Generic name
Angiographic catheter, single-use
Model / reference
13709106
Primary DI / UDI-DI
H787137091060
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
Pressure — 1050 Pound per Square Inch
Outer Diameter — 1.4 Millimeter
Length — 100 Centimeter
Catheter Gauge — 4 French

Related devices

Category: Angiographic catheter, single-use

Cleared under the same submission (K112452)

Show all (12)

Cleared under the same submission (K161596)

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