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EV1000 EVEC12FT

by Edwards Lifesciences LLC

EV1000 EVEC12FT is a Class II device made by Edwards Lifesciences LLC, cleared under FDA 510(k) K160552 on 1 Jun 2016 (1 earlier submission) and listed in FDA GUDID since 3 Sep 2016 (UDI-DI 00690103193619), active as of 22 Oct 2026. 2 FDA recalls are linked to it.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00690103193619 UDI-DI Date3 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK160552 Date1 Jun 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K160552 decided 1 Jun 2016 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00690103193619 listed 3 Sep 2016 Listed

Recalls

2 recalls · FDA

    • Terminated Z-1193-2019 FDA Class I initiated 21 Mar 2019

    Potential for an electrical short circuit leading to possible fire hazard due to liquid ingress into AC power outlets.

    • Terminated Z-1732-2015 FDA Class II initiated 18 May 2015

    Edward Lifesciences is recalling the ClearSight System because the finger component of the Heart Reference Sensor may be damaged.

Timeline

5 dated events

  1. Cleared FDA 510(k) K140312
  2. Recall initiated FDA recalls Z-1732-2015
  3. Cleared FDA 510(k) K160552
  4. Listed FDA GUDID 00690103193619
  5. Recall initiated FDA recalls Z-1193-2019

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
EV1000
Generic name
Electrical-only medical device connection cable, reusable
Model / Ref / Catalog
EVEC12FT
Primary DI / UDI-DI
00690103193619
510(k) Number
FDA product code
DXN, DSB
GMDN term
Electrical-only medical device connection cable, reusable
Device class
Class II
Regulation number
870.1130, 870.2770
GUDID distribution status
In Commercial Distribution
Size
Length — 12 Feet

Related devices

Category: Electrical-only medical device connection cable, reusable

Cleared under the same submission (K140312)

and 8 more cleared under K140312

Cleared under the same submission (K160552)

and 8 more cleared under K160552

Similar devices in this category

Other devices filed under Electrical-only medical device connection cable, reusable.

Other devices from Edwards Lifesciences LLC

See all devices from Edwards Lifesciences LLC →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)