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Truwave PX1800

by Edwards Lifesciences LLC 123 variants

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

Recall on shared 510(k) K142749; other models may be affected

Documents

510(k) K142749

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00690103195378 UDI-DI Date3 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK142749 Date18 Jan 2015DecidedStatusActive

Recalls

11 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0414-2024 FDA Class II initiated 4 Oct 2023 on shared 510(k) K142749
    • Ongoing Z-0413-2024 FDA Class II initiated 4 Oct 2023 on shared 510(k) K142749

    Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

  • 8 recalls, same reason

    • Terminated Z-1961-2021 FDA Class II initiated 26 May 2021
    • Terminated Z-1966-2021 FDA Class II initiated 26 May 2021
    • Terminated Z-1962-2021 FDA Class II initiated 26 May 2021
    • Terminated Z-1963-2021 FDA Class II initiated 26 May 2021
    • Terminated Z-1965-2021 FDA Class II initiated 26 May 2021
    • Terminated Z-1964-2021 FDA Class II initiated 26 May 2021
    • Terminated Z-1959-2021 FDA Class II initiated 26 May 2021
    • Terminated Z-1960-2021 FDA Class II initiated 26 May 2021

    There is a potential that the pressure tubing may detach from the blood sampling system

    • Terminated Z-2776-2015 FDA Class II initiated 31 Jul 2015

    Flow restriction issues in a trifurcated IV set included in the pressure transducer kits. A restriction of the flow of IV fluid would result in either an inability to prime the system before use or difficulty in flushing the line after a blood draw.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Truwave
Generic name
Electrical-only medical device connection cable, reusable
Model / Ref / Catalog
PX1800, 896004023
Primary DI / UDI-DI
00690103195378
510(k) Number
FDA product code
DXO
GMDN term
Electrical-only medical device connection cable, reusable
Device class
Class II
Regulation number
870.2870
GUDID distribution status
In Commercial Distribution
Size
Length — 162 Inch

Related devices

Category: Electrical-only medical device connection cable, reusable

Cleared under the same submission (K142749)

Show all (12)

Other devices from Edwards Lifesciences LLC

See all devices from Edwards Lifesciences LLC →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date

Other properties (12)

  • Supplied sterile: No
  • Sterilise before use: No
  • Single 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
  • Expiration date: No