ECG Lead Wires 590424

by Ivy Biomedical Systems, Inc.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

in data synced 22 Oct 2026

Documents

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

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00816396021662 UDI-DI	Date1 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK942321	Date4 Nov 1994Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00816396021662
FDA 510(k) database 510(k) number K942321

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: ECG Lead Wires
Generic name: Electrocardiographic lead set, reusable
Model / Ref / Catalog: 590424

Primary DI / UDI-DI: 00816396021662
510(k) Number: K942321
FDA product code: DSA
GMDN term: Electrocardiographic lead set, reusable

Device class: Class II
Regulation number: 870.2900
GUDID distribution status: In Commercial Distribution

Size: Length — 30 Inch

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Properties

Lot / batch number

Other properties (14)

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